Responsible Use of Nanotechnologies - BMU...3 Responsible Use of Nanotechnologies Report and...
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Responsible Use of NanotechnologiesReport and recommendations of the German NanoKommission 2011
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Published by: Federal Ministry for the Environment, Nature Conservation and Nuclear Safety (BMU)Public Relations Division • 11055 Berlin • GermanyEmail: [email protected] • Website: www.bmu.de/english
Text:Editor:Expert consultants:
Dr. Antje Grobe, Risk Dialogue Foundation St a.D. Wolf-Michael Catenhusen, Chairman of the German Federal Government's NanoKommission BMU, IG II 6
Design:Printing:
Peter Selbach · www.selbachdesign.de BMU
Photos: Cover image: BASF SE (other figures are listed at page 69)
Date: December 2010
First print run: 2000 copies
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Responsible Use of Nanotechnologies Report and recommendations of the German Federal Government’s NanoKommission 2011
This project was funded by the German Environmental Research Programme (UM 09 61 828)
This report provides the results of the second working phase (2009-2011) of the German Government’s NanoKommission. The Federal Ministry for the Environment, Nature Conservation and Nuclear Safety does not necessarily agree with the content of the report.
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Content
Foreword 6
Summary 8
1 German activities relating to nanotechnologies – the current picture 14
1.1 Preliminary definition of nanomaterials 14
1.2 International context 15
1.3 Research activities 16
1.4 Dialogue activities and public perception 20
1.5 Economic impact 21
2 Findings of the NanoKommission from 2009-2011 24
2.1 Structure and objectives of the NanoKommission’s second dialogue phase 24
2.2 Monitoring implementation of the Five Principles of the NanoKommission 25
2.2.1 Remit of the Issue Group on implementation of the Five Principles 25
2.2.2 Findings of the Issue Group on implementation of the Five Principles 25
2.3 Approaches for preliminary, integrated benefit-risk assessment of nanomaterials and nanoproducts 31
2.3.1 Setting and objectives 31
2.3.2 Developing guidelines for collecting data and comparing benefit and risk aspects of nanoproducts 31
2.3.3 Criteria for preliminary, integrated benefit-risk assessment of nanoproducts 32
2.3.4 Conclusions of the Issue Groups on preliminary, integrated benefit-risk assessment 35
2.3.5 Elaboration of criteria for preliminary assessment of the impact of nanomaterials on human health and the environment 35
2.3.6 Evaluation of the criteria table 38
2.3.7 Conclusions of the Issue Group on elaboration of criteria for preliminary assessment of nanomaterials 39
2.4 Regulation of nanomaterials 41
2.4.1 Remit of the Issue Group on regulation 41
2.4.2 Foundations of the debate on regulation 41
2.4.3 Recommendations on regulation 43
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2.5 “Sustainable Nanotechnologies – Green Nano”: A shared paradigm 48
2.5.1 Remit of the Working Group on developing a shared paradigm 48
2.5.2 Key discussion points for developing a shared paradigm 48
2.5.3 Recommendations of the Working Group on developing a shared paradigm for “Sustainable Nanotechnologies – Green Nano“ 51
3 Final recommendations of the NanoKommission 52
3.1 NanoKommission recommendations on accompanying social and risk-related research 53
3.2 NanoKommission recommendations on the regulation of nanomaterials and nanoproducts 53
3.2.1 EU Regulations and Directives 54
3.2.2 Occupational health and safety 55
3.2.3 Product register 55
3.2.4 Labelling 55
3.3 NanoKommission recommendations on implementation of the principles for responsible use of nanomaterials 55
3.4 Recommendations for further work on criteria for preliminary benefit-risk assessment 56
3.5 Recommendations for developing and applying a shared paradigm (Leitbild) for “Sustainable Nanotechnologies – Green Nano” 56
3.6 Outlook for the German NanoDialogue 57
4 Annex 58
List of abbreviations 58
Links for further information 61
Lists of participants 63
List of Tables 69
List of Figures 69
Foreword
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For the past ten years now nanotechnologies have been
hailed internationally as a fundamental innovation and
key technology. Nanotechnologies are widely expected
to generate a broad range of applications throughout
society and bring innovations in terms of products,
processes and materials for many sectors of the German
economy, with positive impacts on economic growth
and skilled employment, resource conservation and
environmental performance. At the same time, it is
recognised that there is an urgent need to close gaps in
knowledge regarding the potential effects of nanomate-
rials and products manufactured using such materials
on human health and on the environment. Potential
hazards need to be identified in time and precaution-
ary measures put in place. Nanotechnologies present a
window of opportunity to develop a culture of innova-
tion rooted in the precautionary principle. In the inter-
ests of both industry and consumers, we need a broad
innovation strategy guided by the principle of sustain-
ability.
The task assigned to the NanoKommission when it was
set up by the German Federal Government was to foster
responsible use of nanomaterials by facilitating effective
communication between technology development
stakeholders in the realms of science, industry and poli-
tics, and stakeholders in civil society. In an open
process, representatives of environmental and
consumer organisations, a women’s association and a
medical practitioners’ organisation, trade unions,
churches, academia, industry and government bodies
(such as federal ministries and agencies as well as
Länder ministries, on regional state level) discussed
their positions and appraised the issues. The NanoKom-
mission was able to base its work on an extensive net-
work of dialogue on nanotechnologies in Germany.
This report presents the key activities and findings of
the NanoKommission’s second dialogue phase, covering
the period 2009-2011. The number of nanoproducts on
the market increased sharply during this period, but
intensive exploratory work and debate on appropriate
regulation of nanomaterials and nanoproducts also
began to gather momentum, especially within the
European Union. This has already produced some regu-
latory decisions, most notably the new Cosmetics Regu-
lation. The NanoKommission concentrated on continu-
ing and consolidating its work to harness the potential
benefits of nanomaterials for sustainable development,
environmental protection, resource conservation and
human health, and for consumption clusters such as
construction and housing, energy, mobility and com-
munications.
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In this context, a shared paradigm for “Sustainable
Nanotechnologies – Green Nano” may provide useful
guidance both for public research promotion and fund-
ing programmes and corporate product development
strategies.
The NanoKommission also continued in its efforts to
develop and test new methods of risk prevention and
agreed on principles and assessment procedures
enabling prompt preliminary classification of nanoma-
terials on the basis of their potential risks and benefits.
To that end, the NanoKommission launched an in-
depth exploration of principles and options for action
regarding regulation of nanomaterials and nanoprod-
ucts based on the precautionary principle. NanoKom-
mission members found common ground in their
assessment of a range of issues, but opinions were
divided on priorities and preferences, reflecting the
different experiences and expectations of the
stakeholders. This outcome will in fact be particularly
helpful for the debate and decision-making process on
regulatory issues that will follow over the next few
years.
It became clear in the course of the discussions in the
NanoKommission Issue Groups that although the
stakeholders agree on a number of fundamental issues,
views on how this should translate into socio-political
action vary considerably, especially concerning
regulatory issues. This is reflected in the concluding
recommendations of the NanoKommission.
Wolf-Michael Catenhusen
Chairman of the German Federal Government’s
NanoKommission
Summary
The NanoKommission was established by the German
Federal Government in 2006 as a central national plat-
form for dialogue. Its mandate was to foster exchange
among the various stakeholder groups in society on the
potential benefits and risks of nanotechnologies and
thereby promote the responsible use of nanomaterials.
The present report summarises the discussions and out-
comes of the NanoKommission’s second dialogue phase
from 2009 to 2011. During this period the NanoKom-
mission comprised eighteen permanent members repre-
senting a variety of stakeholder groups. The members’
work was supported by four Issue Groups, each consist-
ing of 20-25 members representing ministries and pub-
lic authorities, research and industry, environmental,
consumer and women’s organisations, trade unions and
churches. An additional Working Group comprising
NanoKommission members, research scientists and rep-
resentatives of government authorities was set up to
address the concept of “Sustainable Nanotechnologies –
Green Nano”. All in all, more than a hundred experts
involved in nanotechnologies took part in the lively and
sometimes controversial NanoDialogue debates and
contributed to the findings of this report.
German activities relating to nanotechnologies – the current picture
Some of the fundamental issues addressed by the
NanoKommission are currently also being tackled at
international level. Representatives of various min-
istries, industry bodies and environmental organisa-
tions, for example, are actively engaged in international
consultation processes aimed at establishing a defini-
tion of nanomaterials (Section 1.1), and contribute to
the Working Parties on nanotechnology of the Organi-
sation for Economic Cooperation and Development
(OECD). Beside characterising and assessing the risks of
reference materials, the OECD Working Parties also
pool international research on toxicological and ecotox-
icological testing methods. Germany makes important
contributions in both of these fields (Section 1.2).
The German Federal Government continues to invest in
expanding research on nanotechnologies. In 2010, pub-
lic funding for research from the federal purse was
increased to around EUR 400 million for institutional
research and project-based research. A variety of nation-
al research projects are currently under way, investigat-
ing issues relating to the safe and responsible use of
nanomaterials and their effects on human health and
the environment. About 6.2% of federal spending on
government department projects goes to accompanying
social and risk-related research (Section 1.3)
The broad network of stakeholder dialogues aimed at
facilitating an exchange of knowledge and views in Ger-
many provided another basis on which the NanoKom-
mission has been able to build. In addition, several pub-
lic information and dialogue events have been organ-
ised. The most recent Eurobarometer studies indicate
that the German public is now relatively well informed
regarding nanotechnologies. Of those surveyed, 46%
thought the benefits outweighed the risks, while 29%
believe the risks to be greater
(Section 1.4).
Investment in research and the knowledge generated
by the dialogue process have boosted economic devel-
opment. Some 950 German companies are currently
engaged in developing or marketing nanotechnologies
and nanomaterials at various stages of the value chain,
and the trend is still on the rise. As a result, Germany
remains at the forefront of this market in Europe. Small
and medium-sized enterprises (SMEs) make up the
majority of these companies (Section 1.5).
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Figure 1: 10 nm-tall bismuth stacks on silicon
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The work of the NanoKommission is aimed at fostering
responsible use of nanomaterials in line with the pre-
cautionary principle, preventing risks and advancing
sustainable innovation. It has produced:
suggestions for improving implementation of the
Five Principles for the responsible use of nanoma-
terials (see NanoKommission Report for 2008)
a framework for guidelines for comparative
benefit-risk assessment of nanoproducts
criteria for preliminary assessment of risks posed
by nanomaterials in terms of their impact on
human health and the environment
a statement on regulatory requirements
recommendations for developing a shared
paradigm for “Sustainable Nanotechnologies –
Green Nano”.
Each Issue Group also prepared extensive reports on its
work, Excel spreadsheets and guidelines. These are
available for download at www.bmu.de/nanokommis-
sion/. The results of their work are summarised in brief
below.
Monitoring implementation of the Five Principles for the responsible use of nanomaterials
The remit of Issue Group 1 (Section 2.2) was to examine
how the Five Principles for the responsible use of nano-
materials developed by the NanoKommission in 2008
were being implemented in practice. The group noted
first that there was little awareness of the Five Princi-
ples, even within the sector itself. Measures to imple-
ment the principles were clearly falling short of expec-
tations. Publications by both public authorities and
industry stakeholders made no mention of applying the
principles. This disappointing outcome was put down to
inadequate communication on the one hand, but also
to the fact that many enterprises already applied other
voluntary Codes of Conduct or management standards.
Such companies were deemed to be applying the princi-
ples implicitly. Implicit application of the principles
might be equivalent to explicit application in terms of
the level of protection provided. However, it denies
stakeholders the possibility to reflect on and assess the
processes and instruments used by enterprises and call
for dialogue.
Despite the critical tone of the discussions in Issue
Group 1, by the end of its deliberations some clear
successes had been achieved: major German companies
and industry organisations including BASF SE, German
Statutory Accident Insurance (Deutsche Gesetzliche
Unfallversicherung – DGUV), the German paint and
printing ink industry association (Verband der Lack-
und Druckfarbenindustrie – VdL) and the Federal Insti-
tute for Occupational Safety and Health (Bundesanstalt
für Arbeitsschutz und Arbeitsmedizin – BAuA) included
explicit commitments to the NanoKommission Princi-
ples in their websites, position papers and guidelines.
Some Issue Group and NanoKommission members have
proposed that the granting of public funding should be
made conditional upon a binding commitment to apply
the principles for the responsible use of nanomaterials.
Other members, however, including representatives of
some ministries and authorities and industry represen-
tatives, reject this idea.
Further recommendations of the group focus on obtain-
ing a clear commitment to the principles from different
stakeholders, publishing the principles on the internet
in a form that is accessible and appropriate to target
audiences, and the possibility of organising sector-
specific awareness-raising events. In addition, checklist-
style guidelines should be developed for the predomi-
nantly medium-sized companies in the user industries,
illustrated with examples of good practice. With regard
to monitoring implementation, the Issue Group
reiterated and expanded the recommendations from
the NanoKommission’s first dialogue phase.
Approaches for preliminary, integratedbenefit-risk assessment of nanomaterialsand nanoproducts
For companies engaged in the process of innovation,
preliminary assessment of the benefits and risks of new
technological applications can be a helpful component
of their strategic decision-making. Two Issue Groups
elaborated an important framework as a first step
towards an integrated approach enabling a meaningful
assessment of benefits and risks even where there are
gaps in the available data. The first Issue Group
developed cross-sectoral criteria for screening benefit
and risk aspects of products in their development
phase. Five categories were explored: environment,
Summary
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consumers, employees, society, and company. The
Group also asked what key information was already
available and what measures, if any, should be taken.
The assessment criteria are organised in checklist form,
reflect the various stages in a product’s life cycle (pro-
duction, use, disposal), and compare the properties of
the nanoproduct in development with those of conven-
tional products. The checklist is aimed particularly at
companies involved in processing or disposal further
down the supply chain (informed users) and is intended
as a decision support tool, especially for small and
medium-sized enterprises. The Group recommends
developing the content of the assessment criteria fur-
ther, drawing on scientific expertise to a greater extent.
It also advocates developing the existing Excel spread-
sheets with a view to converting them into a user-
friendly, IT-supported tool.
In the innovation process, those who must ask them-
selves about potential risks associated with their materi-
als are above all the manufacturers and producers of
intermediates in the early stages of the product life
cycle – especially in the case of products intended
for consumer use and/or applications in the open
environment which could result in exposure.
The second Group therefore explored in greater depth
meaningful criteria for a preliminary risk assessment of
nanomaterials, a task which it had already begun in the
NanoKommission’s first dialogue phase. In cases where
a risk assessment required by law or comprehensive vol-
untary risk assessment is available, such assessment
takes the place of any preliminary assessment based on
the criteria presented here. Criteria such as exposure
probability, physico-chemical properties, behaviour in
the environment, toxicology and ecotoxicology were
established on the basis of specific guiding questions. If
information on a particular area is lacking, a note is
made recording that there is a “data gap”. The Group
recommends setting up an advisory body at federal
agency level to assist users to interpret the results and
devise appropriate risk management measures.
Both Issue Groups thought it important that the ulti-
mate aim should be to integrate the elements devel-
oped by them, but this was beyond the scope of the
present work. Both groups also felt that closer coordina-
tion with the Swiss Precautionary Matrix for Synthetic
Nanomaterials would be desirable, along with an
exchange on initial experiences with its implementa-
tion. A detailed description of the Issue Groups and the
guidelines they produced is given in Section 2.3.
Figure 2: Folding arm awning with Swela Sunsilk Nano-Clean fabric
Figure 3: Device for measuring particle size distribution
Positions on the need for regulation
Concerning regulatory matters, another Issue Group
was assigned the task of analysing the existing legisla-
tive provisions at European and national level, of identi-
fying gaps and developing appropriate recommenda-
tions. As well as discussing fundamental issues relating
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to definitions and to the precautionary principle, the
stakeholders also debated the need for action in the
following, often controversial, areas: the EU REACH Reg-
ulation (on the Registration, Evaluation, Authorisation
and restriction of CHemicals), regulatory approaches in
the field of occupational health and safety, the EU Cos-
metics Regulation, various laws relating to foods, and
the EU legislation on biocidal products and plant pro-
tection products. In addition, participants stated their
positions on current policy issues such as the introduc-
tion of a product register and the labelling of consumer
products. Sometimes the Group formulated recommen-
dations on the basis of a shared position, while in cer-
tain areas additional demands expressed by some Issue
Group members were noted. The report also contains
tables presenting and contrasting the various opinions
on specific regulatory areas. The full report of Issue
Group 3 is some 70 pages long. Its key findings are
summarised in Section 2.4 below.
Developing a shared paradigm for “Sustainable Nanotechnologies – GreenNano”
Early in the NanoKommission’s second dialogue phase,
environmental organisations put forward the issue of
“Green Nano” and of developing a shared paradigm for
sustainable technology design. The NanoKommission
convened a small additional Working Group to set out
key features for a shared paradigm and take the first
steps towards developing design criteria.
Design principles include:
Biomimetics: use of local resources and energy
sources, self-organisation as a principle of manu-
facturing, where possible physiological manufac-
turing conditions (soluble materials, pH-neutral,
low pressure and temperature),
Figure 4: Photovoltaic technology based on organic materials
Summary
12
Minimal risk: prevention and reduction of
hazardous structures, morphologies, substances,
functionalities and potential exposures,
Energy and environmental technology: emissions
reduction, environmental monitoring and remedi-
ation, and switching to renewable materials and
energy sources, and
Resource efficiency: preventing/minimising side
reactions, wastes and emissions, low material
intensity, energy efficiency throughout the life
cycle, and recyclability.
The aim of establishing guiding principles of this sort is
to foster socially viable innovations by setting priorities
in line with the principle of sustainability and the pre-
cautionary principle early on in the research and devel-
opment process. This could help to resolve uncertainties
regarding potential benefits and risks, and provide an
early indication of viable paths of innovation. The
Working Group has outlined an initial framework for
guiding principles, and recommends that these should
be developed further in dialogue with the various stake-
holders. It is proposed that this should be supported by
a research project.
Additional recommendations of theNanoKommission
The NanoKommission formulated a number of recom-
mendations to the Federal Government and various
stakeholders. These are summarised below:
Recommendations on research into risks and accompanyingsocial research:
Significantly increase funding for research in this
field.
Close the research gaps in the field of life-cycle
management and prioritise research on consumer
applications and the environmental impacts of
nanomaterials.
Evaluate cross-departmental and multi-stakeholder
research carried out in Germany on the safety of
nanotechnologies. Publish a combined list from
government departments and industry on a
central website. Feed this data into international
databases (e.g. OECD).
Recommendations on regulation:
Update and amend REACH and its Annexes and
the European Chemicals Agency (ECHA) Guidance
documents in a timely manner. Priority should be
given to:
Introduction of a definition of nanotechnolo-
gies and nanomaterials
Adjustment of requirements on provision of
data on substances at the nanoscale
Further review and, where appropriate,
adjustment of the OECD testing methods and
strategies
Requirements and specifications concerning
the incorporation of nano-specific information
in Safety Data Sheets
Adjustment of transitional deadlines for the
registration of substances at the nanoscale
Review of the tonnage thresholds for a nano-
specific assessment programme and chemical
safety reports based on it.
Review current European legislation on biocidal
products and plant protection products to estab-
lish whether current guidelines on testing ade-
quately take into account the specific properties
of nanomaterials, or whether they need to be
amended.
The NanoKommission underscores the recommen-
dations for further work to establish generic
thresholds for occupational health and safety. It
proposes that German contributions in this field
be presented rapidly in the international arena.
Within the NanoKommission and its Issue Groups there
were considerable differences of opinion on the defini-
tion of nanomaterials, on labelling and establishing
nano-specific testing procedures as a prerequisite for
registration, as well as on substance authorisation and
product approval and the issue of a product register. On
these points, therefore, no joint recommendations have
been made.
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Recommendations on preliminary, integrated benefit-riskassessment of nanotechnologies and nanomaterials
Integrate and continue to develop the basic find-
ings of both Issue Groups within a further
research and consultation project involving stake-
holders.
Step up practical testing of the guidelines with
involvement of future users from industry and
small and medium-sized enterprises (SMEs), and
close cooperation with the developers of the Swiss
Precautionary Matrix.
Recommendations on developing principles for “Sustainable Nanotechnologies – Green Nano“
Stimulate multi-stakeholder dialogue to develop
principles and review design criteria.
Recommendations on continuing dialogue in future
The NanoKommission recommends that the Feder-
al Government should continue the dialogue
process on nanotechnology in an appropriate
manner, with continued participation of the stake-
holders involved to date.
Establish a central website on the activities of the
Federal Government and its departments in the
field of nanotechnologies.
The presentation of this second report concludes
the activities of the NanoKommission for the Federal
Government. The NanoKommission thanks all those
who have taken part for their engagement and
contributions.
Figure 5: Scanning electron microscopy image of a coating material for implants (hydroxyapatite granule with stem cells)
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1.1 Preliminary definition of nanomaterials
As yet, the question of what is meant precisely by
nanotechnologies and nanomaterials has not been
answered conclusively at international level. The
NanoKommission and its Issue Groups had to deal with
this uncertainty and decided to base their deliberations
on the preliminary definition established in the
previous dialogue phase.
According to this definition, nanomaterials refers to
engineered materials in the size range typically smaller
than 100 nanometres (1 nm=10-9m) which, primarily as
a result of their altered surface-area-to-volume ratio,
develop new properties. In the course of NanoKommis-
sion discussions, environmental and consumer organisa-
tions expressed concerns about this size range, which in
their view is defined too narrowly. By the time the
NanoKommission was concluding its work, agreement
on a definition had still not materialised, so the second
dialogue phase also relies on the draft prepared in 2008
by the International Organization for Standardization
(ISO Technical Committee 229):
Nano-objects: Materials with one, two or three
external dimensions at the nanoscale (approxi-
mately 1 to 100 nm). Typical examples are
nanoparticles, nanofibres and nanoplates.
Nanofibres include electrically conducting fibres
(nanowires), nanotubes, and nanorods.
Nano-objects are often found in groups.
Nanostructured materials have an internal struc-
ture at the nanoscale and generally occur in com-
pound systems of nano-objects. Typical examples
are aggregates and agglomerates. According to
ISO these are not limited in their physical size or1form.
This definition is regarded as a temporary solution.
Intense debate is currently under way to establish a def-
inition at the level of the European Union2 within its
advisory committees (Joint Research Centre,3 Scientific
Committee on Emerging and Newly Identified Health
Risks (SCENIHR)4), and at international level within ISO
and the Organisation for Economic Cooperation and
Development (OECD). The European Commission has
concluded its consultation on a proposed definition.
As of this writing (December 2010) it is not yet clear,
however, when a decision of the Commission may be
expected.
1 GERMAN ACTIVITIES RELATING TO NANOTECHNOLOGIES – THE CURRENT PICTURE
1 For an explanation of the terms used see also Technical Specification (ISO/TS27687:2008(E)) of 15 August 20082 See European Commission 2010: Commission Recommendation on the definition of the term "nanomaterial", available at:
http://ec.europa.eu/environment/consultations/pdf/recommendation_nano.pdf3 See Joint Research Centre 2010: Considerations on a Definition of Nanomaterial for Regulatory Purposes, available at:
http://ec.europa.eu/dgs/jrc/downloads/jrc_reference_report_201007_nanomaterials.pdf4 See SCENIHR 2010: Scientific Basis for the Definition of the Term "Nanomaterial", available at:
http://ec.europa.eu/health/scientific_committees/emerging/docs/scenihr_o_030.pdf
Figure 6: Emulsion droplets
15
In the NanoKommission’s second dialogue phase the
absence of a definition gave rise to problems as regards
making specific recommendations. The Issue Groups
found that a clear definition of which materials should
be considered nanomaterials is a key prerequisite for all
other deliberations and appraisals. The NanoKommis-
sion therefore welcomes international efforts to estab-
lish uniform nomenclature and standardised terms
relating to nanotechnology.
1.2 International context
In its work on the “Green Nano” principles, on criteria
for preliminary risk assessment of nanomaterials, and
on guidelines for assessing potential benefits and risks
of nanoproducts, the NanoKommission focused on the
early stages of the innovation process. The tools dis-
cussed are intended to provide orientation in situations
where the data needed for a full risk assessment remain
incomplete. Many of the issues relating to subsequent
risk assessment of nanomaterials during the innovation
process are also currently being addressed by the OECD.
The NanoKommission received regular updates regard-
ing progress with work on these issues within the
OECD. In addition, members of OECD Steering Groups
took part in some of the NanoKommission’s Issue
Groups.
The Federal Ministry for the Environment, Nature Con-
servation and Nuclear Safety (BMU) chairs the German
delegation to the OECD Working Party on Manufac-
tured Nanomaterials (WPMN). This delegation compris-
es representatives of the federal authorities and of
research institutes that have expertise in research relat-
ing to the safety of nanomaterials. German industry
representatives are involved in the international indus-
try delegation of BIAC (the Business and Industry Advi-
sory Committee to the OECD). The centrepiece of the
WPMN is its Sponsorship Programme for the Testing of
Manufactured Nanomaterials, in which substance
dossiers are being prepared on 13 representative nano-
materials. As part of this programme, Germany has tak-
en on responsibility for gathering data on nanoscaled
titanium dioxide (TiO2) and contributing key data to the
dossier on nanosilver. It will also provide data on zinc
and aluminium oxides, cerium oxide, and carbon nan-
otubes (CNTs). This work is being coordinated by the
Federal Environment Agency (UBA). OECD test guide-
lines for nanomaterials will be adjusted in the light of
the findings of this testing programme. In the WPMN
Working Groups, accompanying social research has
already produced results, for example an international
database of research projects that address issues of safe-
ty (http://webnet.oecd.org/NanoMaterials). The individ-
ual Working Groups have already delivered and pub-
lished their preliminary findings.5
Alongside the work being done at OECD level, the activ-
ities of the European Union (EU) in the field of research
promotion and regulation are also of considerable inter-
est to the NanoKommission. A new EU Action Plan is
expected to be approved in 2011 setting out EU strate-
gies for the period up to 2015. In preparation for this,
the EU conducted a consultation phase during winter
2009/2010 with all Member States, with national stake-
holder groups in the Member States and associations
and organisations at EU-level.6
EU activities intensified during the NanoKommission‘s
second dialogue phase from 2009-2011, in particular
those relating to regulation. In April 2009 the European
Parliament decided that existing regulation on nan-
otechnologies was inadequate and needed to be
reviewed. The European Parliament called upon the
Commission to conduct a comprehensive risk assess-
ment of nanotechnologies and to establish a binding
Figure 7: Nanostructured titanium dioxide
5 See: www.oecd.org/env/nanosafety6 Public Consultation of the European Commission “Towards a Strategic Nanotechnology Action Plan (SNAP) 2010-2015”, available at:
http://ec.europa.eu/research/consultations/snap/consultation_en.htm
16
legal framework. Referring to various research findings
indicating the toxic effects of some nanomaterials, Par-
liament called for clear legislation to enable sound risk
management. The European Parliament favours intro-
ducing nanoproduct labelling and a corresponding
nanoproduct register. It also called upon the European
Commission to compile an inventory of nanomaterials
and their uses by 2011.7
In November 2009, the recast Regulation (EC)
1223/2009 on cosmetic products (EU Cosmetics Regula-
tion) was promulgated8 and will enter into effect in
2013. In future, under the new Regulation, the use of
nanomaterials must be notified to the European Com-
mission and indicated on product labelling in the list of
ingredients by adding the suffix “(nano)”. Additional
safety data on the use of these substances must also be
provided. In the case of substances intended to be used
as colorants, preservatives and UV filters, an authorisa-
tion procedure applies. The European Commission is
reviewing whether further measures are needed, e.g.
additional data on safety of nanomaterials contained in
products, or regulatory measures. The definition of
nanomaterials used in the Cosmetics Regulation is
based on the position of the Scientific Committee on
Consumer Products (SCCP). The legislator reserves the
right to amend the legislation in the light of any
changes to the definition.
The European Parliament is currently debating a new
draft Regulation to replace Regulation (EC) 258/97
concerning novel foods (Novel Food Regulation). Here
too, compulsory labelling is expected to be introduced.
Consultations on the new Biocides Regulation9 and on
the recast of the RoHS Directive (Restriction of
Hazardous Substances) have yet to be concluded.
Specific provisions relating to nanomaterials are under
discussion for both Regulations. Also under discussion
is mandatory registration under REACH to ensure
traceability of nanomaterials. This idea was considered
and called for at a conference held during the Belgian
Presidency of the Council of the European Union.
The many and varied activities of the EU on regulation
sparked considerable demand for information and
discussion among the NanoKommission stakeholders. In
its second dialogue phase, the NanoKommission there-
fore set up a special Issue Group specifically tasked with
conducting dialogue on issues relating to regulation.
The Issue Group presented its analysis of the current
state of debate in Europe and resulting consequences
and recommendations for the Federal Government in
a 70-page report (downloadable from
www.bmu.de/nanokommission). A summary of this
work on regulation can be found in Section 2.4 below,
and the recommendations of the NanoKommission to
the Federal Government are given at the end of this
report.
1.3 Research activities
The ongoing process of initiating research on risks and
accompanying social research, and of assessing research
findings in dialogue between various stakeholders
groups, is especially important for the work of the
NanoKommission. A number of unresolved questions
from the NanoKommission’s first dialogue phase in
2006-2008 were picked up, for example, by the studies
on nanosilver, on carcinogenicity, and on a nanoprod-
uct register, as set out in the next section. In addition,
this period saw the conclusion of a number of major
research projects relating to key innovations and
research on risks.
Investment in nanotechnologies at federal level
Since the last report of the NanoKommission in 2008,
Federal Government funding for research and develop-
ment of nanotechnologies rose from EUR 339 million to
around EUR 400 million in 2010.10 Of this, a total of
around EUR 370 million is provided by the German
Federal Ministry of Education and Research (BMBF) for
institutional and project-based research on nanotech-
nologies. Other government departments such as the
Federal Ministry for Economics and Technology (BMWi),
the Federal Ministry of Defence (BMVg), the Federal
Ministry for the Environment, Nature Conservation and
Nuclear Safety (BMU), the Federal Ministry of Labour
and Social Affairs (BMAS), the Federal
7 Report available to download at: http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+REPORT+A6-2009-0255+0+DOC+PDF+V0//EN
8 Report available to download at: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2009:342:0059:0209:EN:PDF 9 Cf. Biocidal Products Directive 98/8/EC, and the German Biocidal Products Act (Federal Law Gazette I No 105/2000) 10 All figures for 2010 refer to planned expenditures at the time this report was finalised in December 2010.
17
Ministry of Food, Agriculture and Consumer Protection
(BMELV), and the Federal Ministry of Transport, Build-
ing and Urban Development (BMVBS) together con-
tribute the remaining EUR 30 million. According to an
OECD study, this puts Germany in third place world-
wide behind the USA and Japan for investment in
absolute terms.
Institutional support and donors
Around EUR 178 million of the BMBF funding goes to
the major research institutes funded by the federal and
Länder governments. The German Research Foundation
(Deutsche Forschungsgemeinschaft – DFG), the
Helmholtz Association of German Research Centres
(Helmholtz-Gemeinschaft Deutscher Forschungszentren
– HGF), the Leibniz Association (Leibniz Gemeinschaft –
WGL), the Max Planck Society (Max-Planck-Gesellschaft
– MPG) and the applied research organisation Fraun-
hofer (Fraunhofer-Gesellschaft – FhG) are all engaged in
intensive research into nanotechnologies with a focus
on materials and technology development, measuring
technologies and safety. In addition, there are private
foundations such as the Volkswagen Foundation, Cae-
sar, the Friedrich Ebert Foundation, which is associated
with Germany’s Social Democratic Party (SPD), and the
trade union-affiliated Hans Böckler Foundation; these
all provide resources out of their own budgets for nan-
otechnology research or projects involving dialogue
with the public.
Länder
At the Länder level approximately another EUR 59 mil-
lion (BMBF 2009) in funding is provided out of Länder
ministry budgets. These resources are invested primarily
in supporting medium-sized enterprises and promoting
local knowledge transfer. In recent years a key priority
of investment efforts has been to develop knowledge
within the relevant enforcement authorities. The
NanoKommission has taken this into account by
increasing the number of representatives drafted into
the Issue Groups from the Länder.
The activities of the Federal Government departments
are coordinated by an inter-departmental working
group on nanotechnology and are also integrated into
various joint federal and Länder bodies.
Accompanying social and risk-related research
In the last NanoKommission Report for 2008 the stake-
holders called for a significant increase in funding for
cross-departmental research into risks and accompany-
ing social research. According to the report, funding for
research and development of specific measures relating
to occupational health and safety and protection of
health and of the environment should be increased and
the results made available, in suitably structured form,
to society at large (NanoKommission 2008:10).
Since 2009, annual expenditure on accompanying
social and risk-related research by the Federal Govern-
ment of Germany has stood at around EUR 14 million.
This expenditure primarily represents the specific proj-
ect funding of the BMBF, the BMU, the BMAS and the
BMELV together with the federal agencies accountable
to them. The Federal Environment Agency (UBA), the
Federal Institute for Occupational Safety and Health
(BAuA), the Federal Institute for Risk Assessment (BfR)
and the Federal Institute for Materials Research and
Testing (BAM) also make an important contribution to
research on nanotechnologies in Germany, especially
with regard to issues concerning safety and environ-
mental impact. Other federal institutions also play an
important role, such as the Max Rubner Institute, the
Robert Koch Institute, the Johann Heinrich von Thünen
Institute and the Julius Kühn Institute, as does the Ger-
man Statutory Accident Insurance (Deutsche Gesetzliche
Unfallversicherung – DGUV). Together, these bodies
Figure 8: Scanning electron microscope as an imaging system
18
carry out a multitude of activities relating to the devel-
opment of measuring techniques and to assessment of
nanomaterials. Risk-related research accounts for
around 6.2 per cent of the total EUR 230 million in
federal resources spent on research (government
department projects).11 The research associations
provide additional research funding.
Accompanying social and risk-related researchprojects
In 2007 a joint strategy for research on risk and safety
was established by the Federal Institute for Risk Assess-
ment (BFR), the Federal Environment Agency (UBA) and
the Federal Institute for Occupational Safety and Health
(BAuA). This research strategy is currently under review
to take account of prevailing gaps in the research. Ar-
eas where action is needed will be set out in the Federal
Government’s Action Plan. Austria approved an Action
Plan on Nanotechnology as the outcome of a stake-
holder dialogue process in December 2009, following
Switzerland, which did so in 2008. The USA, with its Na-
tional Nanotechnology Initiative, and the UK both have
cross-departmental, national strategies for nanotech-
nologies, debated by stakeholders and in parliament.
As already mentioned above, efforts are under way at
the OECD level to develop worldwide databases of re-
search on risks and accompanying social research and
to improve transparency in this field.12
In German-speaking countries, there are web pages pro-
viding an overview of risk research and accompanying
social research within the framework of the DaNa Proj-
ect (http://www.nanopartikel.info/cms) and via the
information platform www.nano-sicherheit.de. Below
we present a summary of selected research projects con-
ducted during this NanoKommission dialogue phase
which also influenced its dialogue.
2009, for example, saw the conclusion of three major
BMBF-funded risk research projects (NanoCare, INOSand TRACER). NanoCare characterised eleven nanoma-
terials and conducted a variety of toxicological studies
in vitro and in vivo, as well as research on exposure to
nanomaterials in the workplace. In addition, five public
dialogue exercises were carried out. INOS developed
methods for assessing nanomaterials in vitro, while the
TRACER project addressed issues relating to biocompati-
bility and cytotoxicity of carbon nanofibres. The results
of all three research projects have been collated into a
database, processed and made accessible to the wider
public.
Since 2009, the BMBF has had projects under way with-
in its research support programme NanoNature, which
focuses on research into the impact of nanotechnolo-
gies on the environment. Potential applications for
environmental technologies are also being investigated
alongside research into issues relating to exposure, dis-
tribution and persistence of nanomaterials. A key activi-
ty in this regard is research on measurement technolo-
gies and methods. The NanoNature projects are: Fe-
NANOSIT, NADINE, NanoFlow, NanoKiesel, NanoMem-
brane, NanoPharm, NanoPurification, NanoSan, Nano-
SCR, NanoTrack und NAPASAN.13
CarboSafe 14 with a budget of EUR 2 million, is a proj-
ect of the interdisciplinary group Innovation Alliance
Carbon Nanotubes (Inno.CNT). Research is focused on
Figure 9: Using fluorescence microscopy to analyse cells treatedwith nanoparticles
11 See Federal Ministry of Education and Research (BMBF) (2010): Minor interpellation by Bundestag members René Röspel, Iris Gleicke and others andthe parliamentary group of the SPD on the “Current state and outlook for nanotechnologies”
12 See http://webnet.oecd.org/NanoMaterials/Pagelet/Front/Default.aspx? 13 For more detailed information see: http://www.nanopartikel.info/cms14 For more detailed information on CarboSafe see: http://www.cnt-initiative.de/download/CNT_CarboSafe.pdf
19
developing an online system for analysing carbon nan-
otubes (CNTs), static and portable measuring technolo-
gies, a measuring system and on characterising CNTs
(CarboSafe 2010). Most of the research effort in this area
is being carried out by industry.
The Report of the NanoKommission for 2008 also raised
the issue of nanosilver. Several of the higher federal
authorities addressed this issue. In November 2008 the
Federal Environment Agency published a study on the
assessment of total environmental exposure to silver
ions from biocidal products (Beurteilung der Gesam-
tumweltexposition von Silberionen aus Biozid-Produk-
ten).15 In December 2009 the BfR published an opinion
criticising the use of nanosilver in foods and products
intended for everyday use.16 In the context of the
NanoNature programme mentioned above, a project
entitled UMSICHT is currently investigating the environ-
mental behaviour and fate of silver nanoparticles in tex-
tiles.
Some of the findings of the research projects on risks of
nanomaterials were included in the work of the Issue
Group examining assessment of the benefits and risks
of nanomaterials. The NanoKommission itself took an
explicit stance on the following studies:
In January 2010, a Report of the Federal Environ-ment Agency (UBA) published in autumn 2009 enti-
tled “Nanotechnology for Humans and the Environment
– fostering opportunities and reducing risks” (Nanotech-
nik für Mensch und Umwelt – Chancen fördern und
Risiken mindern) 17 was hotly debated in the NanoKom-
mission. In keeping with the precautionary principle,
UBA recommended minimising or avoiding the use of
products that could release nanomaterials until an
exhaustive risk assessment has been conducted and
grounds for concern ruled out. Criticism by stakehold-
ers was levelled particularly at the public relations work
accompanying the report.
As a result of the last Report of the NanoKommis-sion, the Federal Environment Agency (UBA) and the
Federal Institute for Risk Assessment (BfR) produced a
study on potential cancer risks arising from nanoma-
terials. Following a critical appraisal of the available
data, the study found that there was insufficient infor-
mation for making a general assessment of the carcino-
genic potential of nanomaterials. According to the
study, potential risks can only be assessed at present on
a case-by-case basis in relation to specific substances.
The fact that a number of studies have produced con-
tradictory findings was also perceived as a problem.
While some studies pointed to nano-specific tumori-
genic potential, in other research no carcinogenic
effects were observed. The researchers put this down to
inadequate characterisation of test materials, differ-
ences in design of research experiments, the use of dif-
ferent animal models and species and/or differences in
the dose administered (UBA/BFR 2010: 1). The report
highlighted the need for more research in this area and
recommended efforts to develop and refine standard-
ised methods of testing. In terms of regulation, the sci-
entists at UBA and BfR considered it imperative to cre-
ate a separate category for substances in the nanoform.
Both the methodology and the findings of the study
were criticised by some members of the NanoKommis-
sion. Debate centred on the question of the extent to
which animal experiments at extremely high doses are
meaningful. It was not possible to reach a common
position on the study’s findings. The UBA/BfR carcino-
genicity study and scientific feedback from the German
Chemical Industry Association (VCI) and the BfR are
available as downloads from (www.bmu.de/nanokom-
mission/).18
Another publication that provoked some controversy
was a study on the legal feasibility of a nanoproductregister,19 produced by the Institute for Applied Ecolo-
gy (Öko-Institut e.V.) for the Federal Environment Min-
istry (BMU) in 2010. In this study the authors examine
possible options for a nanoproduct register at European
Union (EU) level and for Germany, and make recom-
mendations on the issue of mandatory product registra-
tion. In other EU countries, such as France and the
15 The UBA study “Beurteilung der Gesamtumweltexposition von Silberionen aus Biozid-Produkten” is available [in German] to download at:http://www.umweltdaten.de/publikationen/fpdf-l/3673.pdf
16 See BfR 2009: “BfR rät von Nanosilber in Lebensmitteln und Produkten des täglichen Bedarfs ab” (BfR advises against the use of nanosilver in foodsand products intended for everyday use), Opinion No 024/2010 of the BfR, 28 December 2009, available [in German] at:http://www.bfr.bund.de/cm/216/bfr_raet_von_nanosilber_in_lebensmitteln_und_produkten_des_taeglichen_bedarfs_ab.pdf
17 The UBA study “Nanotechnik für Mensch und Umwelt – Chancen fördern und Risiken mindern” is available [in German] for download athttp://www.umweltdaten.de/publikationen/fpdf-l/3765.pdf
18 The UBA study on carcinogenicity is available [in German] at: http://www.umweltbundesamt.de/technik-verfahren-sicherheit/publikationen/index.htm
19 Study available [in German] for download at: http://www.bmu.de/files/pdfs/allgemein/application/pdf/bericht_nanoproduktregister_bf.pdf
20
Netherlands there is support for the introduction of a
nanoproduct register and discussions are under way. In
September 2010 the Belgian EU Council presidency also
expressed support for a nanoproduct register. Advocates
of a register emphasise that it would create transparen-
cy regarding nanomaterials on the market, enable pub-
lic authorities to take action, if necessary, to recall prod-
ucts, and help consumers to make informed choices. On
the industry side, meanwhile, the idea of introducing
mandatory registration and a nanoproduct register is
rejected on the grounds that it would entail consider-
able administrative effort and expense. This debate
makes the study all the more topical.
1.4 Dialogue activities and public perception
As was described in the Report of the NanoKommission
for 2008, the nano debate in Germany is distinguished
from debates in neighbouring European countries par-
ticularly by the fact that dialogue was initiated early on.
The diagram below illustrates the variety of activities
for citizens or experts from various stakeholder groups
organised by industry bodies, the scientific community,
environmental and consumer organisations, or by feder-
al or Länder governments. In Germany, nuanced stake-
holder debate has become the established norm. The
Eurobarometer survey report for 2010, moreover, shows
that public knowledge has also increased. 64,7% of Ger-
man citizens have heard of nanotechnologies (com-
pared to an EU average of 46,3%). 46% think the bene-
fits outweigh the risks, while 29% believe the risks are
greater.20
In addition to setting up the NanoKommission, the Fed-
eral Government has also initiated various information
and dialogue events in connection with nanotechnolo-
gies aimed particularly at German citizens. These
include events such as the public dialogue held in sum-
mer 2010 as part of the Duisburg “Environment Mar-
ket” (Duisburger Umweltmarkt), the NanoTruck road-
show,21 brochures, focus groups and consumer confer-
ences.
On the industry side, representatives of the German
Chemical Industry Association (VCI), sub-sector associa-
tions and their member companies took part in various
national and international dialogue initiatives. Special-
ist conferences were organised by the German Society
for Chemical Engineering and Biotechnology,
DECHEMA. Participants also included stakeholders from
the scientific community, public authorities and NGOs.
DECHEMA also ran a competition for schoolchildren22
in which young people were asked to devise nanotech-
nology experiments. BASF’s “Dialogueforum Nano”,
meanwhile, brought together environmental and con-
sumer organisations, trade unions and churches with
company representatives to develop recommendations
on the issues of information and transparency through-
out the product life cycle. The trade union IG BCE (Min-
ing, Chemical and Energy Industrial Union) conducted
an open workshop on prospects for nanotechnology
innovations. In the Länder too, for example in Hesse,
Baden-Württemberg, Saxony, Bavaria, Rhineland-Palati-
nate, Saarland and North Rhine-Westphalia, events of
various types were organised concerning nanotechnolo-
gies. These ranged from information events for SMEs or
the general public to consultative dialogue with experts
within Länder government bodies.
Friends of the Earth Germany (BUND) continued to hold
its annual series of events on nanotechnologies. These
were run in conjunction with the Protestant Academy
in Villigst. With titles such as “Nanotechnologies – Quo
Vadis?” and “New Technologies and Sustainability –
Green Nanotechnologies as a new model?”, these events
brought together experts and interested lay people to
debate what would constitute a socially desirable future
for nanotechnologies. In 2008 the Federation of Ger-
man Consumer Organisations (VZVB) carried out a
study entitled “Nanotechnologies: what consumers
want to know” (Nanotechnologien: Was Verbraucher
wissen wollen); it also published a position paper and
conducted debates on the theme “A closer look at the
miniature world of nanotechnologies” (Im Reich des
Winzigen – Nanotechnologien unter der Lupe) with var-
ious stakeholders in Berlin.
20 Cf. European Commission 2010: Europeans and Biotechnology in 2010. Winds of change?, A report to the European Commission’s Directorate-Gen-eral for Research, available at: http://ec.europa.eu/public_opinion/archives/ebs/ebs_341_winds_en.pdf
21 For further information see: http://www.nanotruck.de/22 For further information on the event Nano erleben – Abschlussveranstaltung des bundesweiten Wettbewerbs Nanotechnologie-Demonstrationsver-
suche (Experience nano – closing event in the nationwide competition on Nanotechnology demonstration experiments) see: http://events.dechema.de/NanoDemo.html
21
The NanoKommission, however, with its five
Issue/Working Groups, a total of 28 dialogue sessions,
a mid-term public presentation and a final conference
in February 2011, remains a key instrument for dia-
logue in the exchange between science, politics and
public authorities, industry and NGOs.
Without claiming to be exhaustive, the diagram on
page 22/23 provides a snapshot of the varied activities
in which the NanoKommission has engaged.
1.5 Economic impact
Systematically encouraging sustainable innovation is
one of the keys to fostering economic growth and
prosperity in the view of the German Federal Govern-
ment, especially in difficult economic times. Activities
relating to nanotechnologies are coordinated by the
Federal Government’s “Nano Initiative – Action Plan
2010”, in place since 2006, and its High-Tech Strate-
gies. As a driving force for innovation, nanotechnolo-
gies are also given pride of place as a key technology in
the new “High-Tech Strategy 2020 for Germany”.23 In
recent years research efforts and market applications
for nanotechnologies in specific products and services
have received a major impetus. Around 950 enterprises
are currently engaged in the development, manufac-
ture and distribution of nanotechnology-based products
and processes in Germany. About 80% of these are
SMEs.24 This puts Germany at the head of the field in
Europe. According to BMBF data more than 60 000 jobs
in industry depend on the use of nanotechnologies and
nanomaterials. Moreover, three of the world’s five
largest manufacturers of nanomaterials, BASF SE, Bayer
Material Science AG and Evonik AG are headquartered
in Germany. German industry therefore has a signifi-
cant role to play in developing and establishing meth-
ods for the responsible use of nanomaterials through-
out their life cycle.
Enterprises are supported by powerful industry federa-
tions. The German Chemical Industry Association (VCI),
the Society for Chemical Engineering and Biotechnolo-
gy (DECHEMA), the Association of German Engineers
(VDI), the German Cosmetic, Toiletry, Perfumery and
Detergent Industry Association (IKW), the Federation
for Food Law and Food Science (BLL) and the German
paint and printing ink industry association (VdL) have
organised a large number of information and dialogue
events on nanotechnologies in recent years, as well as
exchange of knowledge with their member companies.
In connection with its High-Tech Strategy in particular,
the Federal Government is banking on the potential of
nanotechnologies to make a major technological contri-
bution to resolving some of most pressing challenges
facing society today, such as climate change, demo-
graphic change, mobility, civil security and communica-
tions. The German economy has also benefited from the
huge investment in nanotechnology research and devel-
opment.
Dialogue among stakeholders has also supported the
process of awareness-raising and has identified impor-
tant risk-related issues. The job of the NanoKommission
is to drive this process forward along the path of
responsible, sustainable development in dialogue with
the different stakeholder groups, taking into account
from the outset potential risks to the environment and
to human health and addressing them adequately.
Figure 10: X-Seed precast concrete components
23 For further information on the German Federal Government’s High-Tech Strategy see: http://www.hightech-strategie.de/24 See Federal Ministry of Education and Research (BMBF) (2010): Minor interpellation by Bundestag members René Röspel, Iris Gleicke and others and
the parliamentary group of the Social Democratic Party (SPD) on the “Current state and outlook for nanotechnologies”, BT-Drs. 17/3557, 11 Novem-ber 2010
Dial
ogue
at
Fede
ral l
evel
Dial
ogue
at
Länd
er le
vel
Stak
ehol
der
dial
ogue
Publ
ic d
ialo
gue
2004 20062005
NanoTruck roadshow
NanoTruck roadshow
NanoTruck roadshow
Nano meets environmental
technology, Baden-Württemberg
NanoCommunica-tion Hesse
StMUGV Nanotech-nology Forum,
Bavaria
Nanoparticle Appli-cations and Risks,
Baden-Württemberg
BUND conference,Iserlohn Protes-tant Academy
VCI dialogue serieson occupational
health and safety
BMBF: Nano DE2004
BfR Expert Dialogue
BMU NanoDialogue
Public dialogue,German Hygiene
Museum in Dresden
BUND conference,Iserlohn Protes-tant Academy
IKW dialogue onnano in cosmetics
BASF “Dialogue -forum Nano”
BfR Expert Dialogue
NanoKommission with 3 Working Groups
BMBF: Nano DE2006
Deutsches Museum Munichnano-dialogue
Hesse in dialogue: Nano-this is the future
VCI Future Forum
BfR/UfU publicconferences
Examples of the German Dialogue Landscape on Benefits
22
23
2007 20102008 2009
NanoTruck roadshow
NanoTruck roadshow
NanoTruck roadshow
NanoTruck roadshow
NanoStandardis-ation, Hesse
NanotechnologyForum, Hesse
NanoKommission with 3 Working Groups
BfR Expert Dialogue
The Greens Parliamentary
group
NanoKommission with 5 Issue/Working Groups
NanoBioNetpublic dialogue
Duisburg publicdialogue
Conference ofConsumer Protec-
tion Ministers(VSMK)
NanoDialogueBaden-Württem-
berg
NanoCare publicdialogues
NanoCare publicdialogues
BUND conference,Iserlohn Protes-tant Academy
VCI dialogue serieson occupational
health and safety
Expert Dialogue,Consumer
Associations
BASF “Dialogue-forum Nano”
NanoDialogue,Rhineland-Palatinate
Nanosilver,Hesse
NanoConference,North
Rhine-Westphalia
Nanotech Week,Frankfurt, Hesse
BUND conference,Protestant
Academy, Villigst
Nanotechnologyfor people andhealth, Hesse
BASF “Dialogue-forum Nano”
BUND conference,Protestant
Academy, Villigst
VCI dialogue series on Safety
Data Sheets
Nano Forum
DECHEMA
BASF “Dialogue-forum Nano”
VZBV dialogue
IG BCE
NanoBioNet
BUND conference,Protestant
Academy, Villigst
BASF “Dialogue-forum Nano”
Institute for Applied Ecology
DECHEMA
NanoKommission with 3 Working Groups
Friedrich EbertFoundation
NanoMedicineFriedrich Ebert
Stiftung
NanoKommission with 5 Issue/Working Groups
Christian DemocraticUnion/Christian So-
cial Union (CDU/CSU)Parliamentary group
Euro-Bio-NanoBfR Expert Dialogue
Euro Nano Forum
VCI Future Forum
Deutsches Museum Munichnano-dialogue
Youth Forum“Nanomedicine”
and Risks of Nanotechnologies
Congress of the German Protestant
Church (DEKT)
24
2 FINDINGS OF THE NANOKOMMISSION 2009-2011
2.1 Structure and objectives of theNanoKommission’s second dialoguephase
Following its first dialogue phase from 2006-2008, the
NanoKommission was reconvened for a second phase
and the number of members increased to eighteen
according to the mandated programme of work. The
NanoKommission was intended to be a central, interdis-
ciplinary and multi-stakeholder dialogue platform with
the task of advising the Federal Government. A total of
more than 100 experts were involved in five Issue/Work-
ing Groups and in the coordinating NanoKommission.
Representatives of ministries at federal and Länder level
and of higher federal authorities, from the scientific
community, industry and NGOs (trade unions, environ-
mental and consumer organisations, churches and
a women’s organisation) worked together on issues
concerning the responsible use of nanomaterials.
At the beginning of the process, the following objec-
tives were agreed for the work of the NanoKommission
itself:
To foster continuous exchange among interest
groups and develop the communication structures
established in the first dialogue phase
To ensure that the whole work process continu-
ously focuses on priority issues and cross-cutting
issues
To discuss, take decisions on and publish the find-
ings of the NanoKommission’s Issue/Working
Groups
To formulate recommendations to the Federal
Government and, where relevant, to other stake-
holders
To comment on legislative processes (EU, national)
To comment on the state of risk research and on
any consequences arising out of this for the imple-
mentation of legislation.
In February 2010 an interim review of the work of the
NanoKommission’s Issue/Working Groups was held in
the form of a dialogue forum. The purpose of this event
was to present preliminary findings and hold discus-
sions with the interested public and experts.
The following sections of this report summarise the
findings of the Issue/Working Groups at the end of
their dialogue phase in autumn 2010 and present
recommendations with regard to possible next steps.
The detailed original documents on the work of the
Issue/Working Groups are available to download from
the website of the Federal Environment Ministry
(BMU – www.bmu.de/nanokommission/). Also available
are the Excel spreadsheets on preliminary benefit and
risk assessment, with guidelines on proper application
and additional explanations. At the end of the Report
(Section 3), the NanoKommission draws its own conclu-
sions and makes recommendations based on the find-
ings of the Issue/Working Groups.
During its second dialogue phase the NanoKommission
had the support of an external coordination office, pro-
fessional moderation and dialogue management and
additional support for the preparation and coordina-
tion of its final report.
Figure 11: Fracture surface of a nano-modified glass fibre compositewith CNT
25
2.2 Monitoring implementation of the Five Principles of the NanoKommission
2.2.1 Remit of the Issue Group on implementation of the Five Principles
In the first Nano Dialogue phase, the former Working
Group 3 produced a paper setting out Five Principles
for the responsible use of nanomaterials.
These Five Principles are:
1. Definition and disclosure of responsibility and
management (good governance)
2. Transparency regarding nanotechnology-related
information, data and processes
3. Commitment to dialogue with stakeholders
4. Establishment of risk management structures
5. Responsibility within the value chain
These principles were published in the Final Report of
the NanoKommission for 2008.
In the Final Report on the first dialogue phase, the
NanoKommission recommended that implementation
of the principles should be monitored, names of compa-
nies/sectors which had committed to implementing the
principles should be published, and that the principles
should be reviewed after two years. They also recom-
mended that the Principles Paper should be extended
to apply to other sectors that use nanotechnologies or
nanomaterials.
The NanoKommission’s remit to the new Issue Group
for the second dialogue phase was directly related to
these recommendations:
To monitor implementation of the principles for
the responsible use of nanomaterials within the
chemical industry (manufacturers of nanomateri-
als and of preparations which contain nanomate-
rials), to assess “principles” as an instrument and
potential ways to optimise them.
To expand the recommendations on practical
guidelines for implementing the principles, espe-
cially to include issues relating to environmental
and consumer protection.
To give concrete form to this basic mandate of the
NanoKommission, the Issue Group divided its work into
the following four “packages”:
1. Review the use of guidelines to specify the
principles
2. Assess approaches for monitoring implementation
of the principles
3. Expand the recommendations in the areas of
environmental and consumer protection
4. Discuss options for extending the scope of the
principles to cover other sectors.
First of all the Issue Group sought to obtain an overview
of awareness of the NanoKommission’s Principles with-
in the different sectors and of how widely they were
being implemented. To do this it used information from
a survey conducted by the VCI and analysed the guide-
lines produced by various sectors and companies which
use nanomaterials. The results of this stock-taking exer-
cise gave rise to intense debate and a produced a num-
ber of recommendations. The original Issue Group
report on the course of the discussions and their
outcome is available as a downloadable document
(see above).
2.2.2 Findings of the Issue Group on implementation of the Five Principles
Awareness of the Five Principles
In winter 2009/2010 the German Chemical Industry
Association (VCI) carried out a survey of its member
organisations. Included in the questionnaire were a
number of questions on implementation of the
NanoKommission Principles. Out of 40 companies sur-
veyed, 17 responded to the questions concerning the
principles. Evaluation of the results by the VCI revealed
that at the time of the survey none of the respondent
companies made an explicit reference to the NanoKom-
mission Principles.
Telephone interviews conducted by the Issue Group
chairman with individual SMEs outside the chemical
industry yielded a similar picture. Only a few of the
respondents were aware that the Federal Government’s
NanoKommission even existed. None of the respondents
in the SME sector were aware of the principles for the
responsible use of nanomaterials.
26
Several possible reasons for this were put forward:
Aside from holding an event to mark the publica-
tion of its final report, the NanoKommission did
not actively communicate its work. The Report of
the NanoKommission which contains the princi-
ples was not actively sent out to companies or
sectoral bodies using nanomaterials.
The principles were not published in a separate
document. Instead, they were included in the
NanoKommission’s 70-page Report for 2008. This
was perceived to be not very reader-friendly and
hampered ease of access.
The findings of the NanoKommission have so
far only been published on the web pages of the
Federal Environment Ministry (BMU).
Other public bodies at federal and Länder level
which provide information on nanotechnologies
make no reference and provide no links to the
principles.
Industry bodies and large enterprises make no
mention of the NanoKommission Principles in
their web pages, or of any awareness-raising
events related to them.
Beyond the controversially debated questions of the
attribution of responsibility in this matter, the Issue
Group makes the following recommendations:
Partners in the NanoDialogue (public authorities,
industry, trade associations, trade unions, church-
es and consumer organisations) should publicly
express their commitment to the principles for
the responsible use of nanomaterials, e.g. by
including a specific declaration on their websites.
Participants in the NanoDialogue should actively
communicate the approach to other, non-partici-
pating companies, industry bodies and institu-
tions.
The Five Principles of the NanoKommission
together with their accompanying explanations
should be published in separate brochures.
These brochures could be developed for example
by the BMU and the industry associations and
made easily accessible to interested parties,
including via the internet.
Public awareness-raising events on the responsible
use of nanomaterials should be organised/attended
to publicise and foster debate on the NanoKommis-
sion Principles. This applies especially to events run
by the relevant ministries and industry associations.
In this context it would be desirable to extend the
scope of the principles to cover other sectors using
nanomaterials as soon as possible.
Efforts to include environmental and consumer
protection aspects in recommendations for guide-
lines should be continued, taking into account the
initial contributions from the discussions of the
Issue Group.
Inclusion of the principles in sector guidelines and companycodes of conduct
Alongside the results of the VCI survey, the additional
interviews with individual SMEs and analysis of web-
sites, the Group also carried out a review of sector
guidelines and company codes of conduct to ascertain
whether they made any direct reference to the princi-
ples, or whether the principles were being implement-
ed in other ways. The Issue Group found that, eighteen
months after the principles had been approved, not a
single company or industry association specifically men-
tioned the principles in its literature although some
had in fact been directly involved in developing them
in the course of the last dialogue phase of the
NanoKommission. Many companies and industry bod-
ies, however, already apply other principles relating to
the responsible use of nanomaterials, which cover simi-
lar areas. One such example is the Responsible Care®
Charter of the chemical industry, or the various compa-
ny codes of conduct reviewed by the Group (see
detailed Report of the Issue Group).
Two of the companies participating in the dialogue
(BASF SE and Bayer Material Science AG), and the VCI
were examples where established management and
communication practices were in place that covered
the substance of the principles. In the case of sector
guidelines, it should be noted that the guidelines exam-
ined by the Group had all been in place prior to the
27
publication of the NanoKommission Principles in 2008,
with the exception of the German paint and printing
ink industry association guidelines.
As regards implementation of the principles, the Issue
Group therefore drew a distinction between:
1. “Explicit” commitment, where the company in
question “publicly” declares its commitment to
implementing the principles for the responsible
use of nanomaterials; and
2. “Tacit” commitment, where the company declares
that implementation of the relevant sections of
the principles for the responsible use of nanoma-
terials is carried out within the company divisions
concerned. However, the company makes no clear,
outwardly evident connection between this prac-
tice and the NanoKommission Principles. Instead,
it implements them “implicitly”, e.g. as part of
general company governance.
In the subsequent discussions it became clear that even
where the content of an organisation’s guidelines is simi-
lar, implicit implementation is neither visible nor verifi-
able from outside the company. Implicit implementation
was considered to be just as appropriate as explicit imple-
mentation in terms of the level of protection provided – all
of the dialogue partners agreed on this point – but it does
not offer the possibility for external stakeholders to scruti-
nise processes and instruments and to request dialogue
initiatives. This drawback was emphasised particularly by
the NGOs and public authorities. As pointed out by the
NGOs, it also runs counter to Principle 2 for the responsi-
ble use of nanomaterials, the transparency principle.
In the course of the Issue Group’s dialogue, BASF SE intro-
duced a specific reference to the NanoKommission Princi-
ples and provided a link to the original document.25 Ger-
man Statutory Accident Insurance (DGUV), another mem-
ber of the Issue Group, produced a position paper making
specific reference to the Five Principles.26 The German
paint and printing ink industry association (VdL) also
included explicit mention of the NanoKommission Princi-
ples in its new sectoral code of conduct on the responsible
use of nanomaterials in the workplace.27
Towards the end of the NanoKommission’s second dia-
logue phase the Federal Institute for Occupational Safe-
ty and Health (BAuA) also published a declaration of
explicit commitment to the principles for the responsi-
ble use of nanomaterials and outlined plans for their
implementation.28
In its Report, the Issue Group reiterates the recom-
mendation from the NanoKommission‘s first dia-
logue phase calling for the provision of an inter-
net platform publishing the names of companies,
industry associations and institutions implement-
ing the principles or taking them into account. It
remains to be clarified whether these companies,
industry associations and institutions would input
this information themselves or whether a third
party would be commissioned to undertake this
task according to a set of criteria still to be estab-
lished.
Figure 12: Measuring nanoparticles with a scanning mobilityparticle sizer (SMPS)
25 See: http://www.basf.com/group/corporate/de/sustainability/dialogue/in-dialogue-with-politics/nanotechnology/code-of-conduct26 See: "Verantwortungsvoller Umgang mit Nanomaterialien – Position der gesetzlichen Unfallversicherungen” (Responsible use of nanomaterials –
Position of the Statutory Insurers), available [in German] at: http://www.dguv.de/inhalt/praevention/themen_a_z/nano/Positionspapier_Nano.pdf27 See: "VdL-Leitfaden für den Umgang mit Nanoobjekten am Arbeitsplatz" (VdL guidelines for the use of nano-objects in the workplace), available
[in German] at: http://www.arbeitsinspektion.gv.at/NR/rdonlyres/DD4883A5-FDFE-481E-B852-D41721D4567A/0/Vdl_Nanoleitfaden_Lacke.pdf
28
Further development in the form of guidelines and othersupport for implementation
From the perspective of users of nanomaterials in indus-
try, the NanoKommission Principles need to be given
concrete form for implementation in practice, for exam-
ple by means of sector-specific guidelines of the indus-
try associations. During the second phase of the Nan-
oDialogue, the VdL produced just such a set of guide-
lines for the German paint and printing ink industry. A
joint code of conduct for occupational health and safety
had already been put in place by the VCI and the BAuA
before the Five Principles were developed in the Nan-
oDialogue process. The VCI also had a number of guide-
lines on specific issues relating to the use of nanomate-
rials. These were used in developing the five NanoDia-
logue Principles. According to industry representatives,
other sector-specific guidelines are currently being
drawn up. Differences in focus and in depth of detail of
these guidelines are due to differing requirements for
the responsible use of nanomaterials in different indus-
trial sectors of application. Industry representatives
therefore do not consider it useful to establish a general
format for guidelines with identical criteria for all
sectors.
The way of implementing the princi-
ples should be based on the specific
conditions of each company, such as
company size, position in the value
chain, and the nature of a company’s
products. Implementation aids like
guidelines must allow for diversity of
this sort.
In addition, it might be appropriate
for such guidelines implementing the
principles into organisational routines
to vary the depth and specificity of
elaborating the principles according
to the management and risk commu-
nication structures already in place.
This is something that should also be
considered when applying the assess-
ment or testing matrices devised by
the other Issue Groups.
The Issue Group recommends that the NanoKommission
should make the evaluation matrix (see below) available
to authors of guidelines and codes of conduct to facilitate
comparison and adjustment. The current version of the
evaluation matrix produced by the Issue Group is a work
in progress and requires further development if it is to be
used widely to make definitive appraisals, should the
need arise as a result of new guidelines being produced
on the basis of the principles.
Criteria were evaluated qualitatively using a three-level
scoring system: (-) = criterion has not been addressed;
(o) = criterion has been partially/inadequately
addressed; (+) = criterion has been addressed in
full/extensively.
In order to provide interested stakeholders in industry
with tools that are fit for purpose, the Issue Group
believes it would be desirable to produce examples of
implementation tools based on agreement between
the partners in the NanoDialogue. This would entail
especially
Elaboration of a model set of guidelines for user
industries, taking into account the predominance
Figure 13: Using a shaker to test the release of nanomaterials under mechanical stress
28 See BAuA (2010): Umsetzung der Prinzipien zum verantwortungsvollen Umgang mit Nanomaterialien der NanoKommission der Bundesregierung(Implementing the principles for the responsible use of nanomaterials of the German Federal Government’s NanoKommission), at:http://www.baua.de/de/Themen-von-A-Z/Gefahrstoffe/Nanotechnologie/Nanomaterialien.html. On the Activities of the BAuA (2010), see: Forschungund Entwicklung zu Nanomaterialien am Arbeitsplatz (Research and development relating to nanomaterials in the workplace), available at:http://www.baua.de/de/Themen-von-A-Z/Gefahrstoffe/Nanotechnologie/pdf/Forschung-Entwicklung.pdf?__blob=publicationFile
29
of medium-sized enterprises (with guidance for
action, checklist-style layout, encompassing all
areas of activity).
Setting out examples of Good Practice, showing
how larger enterprises in the sector have integrat-
ed the NanoKommission Principles into their exist-
ing structures.
Table 1: Matrix for evaluation of guidelines
Criteria Evaluation
Principles addressed(Qualitative assess-ment -, 0, +)
Principles givenconcrete form(Qualitative assess-ment -, 0, +)
Equal consideration given to all protection targets (occupational health & safety / environment /consumers)
1 Definition and disclosure of responsibility and management (good governance)
Definition of responsibility in the management context
Clarity of definition to outsiders
Regular or continuous reporting
Establishment of a clear and verifiable management system
2 Transparency regarding nanotechnology-related information, data and processes
Information on use of nanomaterials and products derived from them
Information on relevant safety assessment issues
Information on measures applied and recommended for safe use
Information presented in appropriate way for target audience
3 Commitment to dialogue with stakeholders
Conducting or fostering dialogue with interested stakeholders
Evaluation of dialogue activities
4 Establishment of risk management structures
Appropriate application of the precautionary principle
Indications of possible substitution testing
Involvement of final consumers and partners in the supply chain
Documentation of knowledge gaps
Appropriate involvement in safety research
5 Responsibility within the value chain
Availability of central basic data for toxicological and ecotoxicological assessment
Use of communication options
Policy transparency
Monitoring
As a possible instrument for monitoring implementa-
tion, the VCI suggested conducting a survey of its
member companies. As described above, a first survey
was carried out in 2009.
30
The other dialogue participants welcomed this volun-
tary initiative. At the same time, however, they per-
ceived this first survey of the use of nanomaterials in
industry as inadequate as it was limited to the relatively
narrow circle of active VCI members. Some dialogue
participants also pointed out that a survey does not
equate to independent monitoring of implementation.
For the kind of monitoring that delivers scientifically
sound results and is accepted as independent by third
parties, there would have to be not only a statistically
relevant population, but also above all transparent eval-
uation methods and independent verification. In addi-
tion, financial support would be needed from external
donors. The Issue Group discussed how monitoring
of this sort could be carried out as promptly and as
economically as possible:
During the dialogue process, the VCI offered to include
questions on the principles in its general Responsible
Care survey in future with a view to achieving broader
dissemination and generating stronger commitment to
take part in the survey. This would also serve the pur-
pose of spreading awareness of the principles and
broaden the reach of the survey on the use of nanoma-
terials within the chemical industry. Moreover, the data
could be checked by auditors, thus ensuring independ-
ent third-party verification.
Some participants also expressed the desire to be
involved in the actual design of methods for transpar-
ent evaluation of the results. The VCI offered to involve
the stakeholders in the survey design process.
Conclusions of the Issue Group
In this second dialogue phase the Issue Group
addressed the issue of implementing the NanoKommis-
sion Principles. Representatives of the trade unions,
environmental organisations and consumer associations
stated that implementation by companies and industry
associations had fallen short of their expectations. For a
variety of reasons, implementation of the principles by
companies tended to be implicit rather than explicit.
Although implicit implementation might be just as
good as explicit implementation in terms of the level of
protection provided, it denies stakeholders the possibili-
ty of ensuring transparency and of scrutinising the
processes and instruments used. One positive develop-
ment, however, was the fact that during the course of
the dialogue four companies and industry associations
decided to lead the process by taking the initiative of
developing guidelines.
Some members of the Issue Group proposed that the
granting of public funding should be made conditional
upon a binding commitment to apply the principles for
the responsible use of nanomaterials that were devel-
oped in the NanoKommission’ first dialogue phase and
reinforced in the second phase. The Federal Institute for
Occupational Safety and Health (BAuA) has already
decided to go down this route. Other members, includ-
ing representatives from the ministries, from other pub-
lic bodies and from industry reject this idea, pointing
out that EU research funding is granted on the basis of
the “Code of Conduct for Responsible Nanosciences and
Nanotechnologies Research”.
Despite all the obstacles and hitherto unfulfilled expec-
tations, the Group thinks it would be useful to continue
to monitor the implementation of the principles and to
define them in more detail. This will allow the potential
of this approach to be developed and exploited.
In general terms, the content of the Five Principles of
the NanoKommission for the responsible use of nano-
materials continues to have the full backing of all the
dialogue partners.
31
2.3 Approaches for preliminary, integrated benefit-risk assessment of nanomaterials and nanoproducts
2.3.1 Setting and objectives
The mandate of the Federal Government’s NanoKom-
mission is to gather all the information available on
benefits and risks of nanomaterials and nanoproducts
in dialogue with different stakeholders, and thus foster
the responsible use of nanomaterials. This is particular-
ly important in the early stages of development of a
technology like this due to the uncertainties surround-
ing it. In this context it makes sense to set out pragmat-
ic approaches for orientation and assessment that take
equal account of economic, environmental and social
considerations before a product reaches the market-
ready stage.
Between 2006 and 2008 the NanoKommission devel-
oped criteria for carrying out a preliminary risk assess-
ment of nanomaterials in situations where a complete
data base was not yet available. The idea behind this
was to give companies a straightforward way of classify-
ing their materials into categories ranging from “proba-
bly not hazardous” to “probably hazardous”. This grad-
ing system can then be used as a basis for recommend-
ing appropriate measures. As a means of providing
initial orientation, the preliminary risk assessment
was welcomed by the stakeholders. At the same time
it was emphasised that the criteria used for prelimi-
nary risk assessment needed to be refined and, in
more general terms, that the framework for prelimi-
nary risk assessment needed to be expanded. The
need for integrated consideration of potential benefits
and risks was highlighted by the experience of Work-
ing Group 1 in the NanoKommission’s first dialogue
phase. The remit of this group was to identify poten-
tial benefits of nanotechnology for society. It became
apparent that a methodological framework was need-
ed in order to be able to make any sensible pro-
nouncements regarding potential benefits, too. The
methodological framework should include integrated
consideration of potential benefits and risks from the
outset, because it is only by weighing up these two
aspects that any judgement can be made as to
whether a particular nanotechnology application has
potential benefits for society.
The NanoKommission therefore set up two Issue Groups
to establish a basic framework for an integrated risk-
benefit assessment and to continue developing the
approaches devised during the previous dialogue
phase. One of the Groups focused primarily on the
potential benefits and risks of nanoproducts, while the
other set out to establish categories for preliminary risk
assessment of nanomaterials themselves.
Figure 14: Folding arm awning with Swela Sunsilk Nano-Clean fabric
2.3.2 Developing guidelines for collecting dataand comparing benefit and risk aspects ofnanoproducts
The first Issue Group, comprising around 20 stakehold-
ers, put forward guidelines for gathering data and com-
paring the benefits and risks of nanoproducts through-
out their life cycle. The Group’s members developed a
set of criteria for integrated benefit and risk assessment
at the product development stage and summarised
these in the form of preliminary guidelines. Key compo-
nents include a product profile, a catalogue of benefit
criteria and a set of risk criteria. In line with the
groundwork on preliminary risk assessment carried out
in the NanoKommission’s previous dialogue phase, the
group elaborated cross-sectoral evaluation criteria.
These are divided into five categories: environment,
32
consumers, employees, society and company. The inclu-
sion of social considerations here offsets the largely nat-
ural sciences-based focus of Issue Group 4. Using a
checklist-style approach, the first step in the evaluation
reveals any benefit and risk-related considerations that
may arise at the different stages of a product’s life cycle
(manufacture, use, disposal) and how the product com-
pares to a conventional reference product (not involv-
ing nanotechnology).
The objective of these efforts is to provide enterprises
with a basis for making strategic decisions early on in
the innovation process on the one hand, while also cre-
ating a systematic basis for dialogue between industry,
consumer organisations and public authorities.
Complementing these efforts, the Issue Group formulat-
ed directions for carrying out product evaluation and
presenting the results. As mentioned above, the com-
plete report of the Issue Group containing the draft
guidelines, directions and an Excel spreadsheet with
examples illustrating how they would be used in
practice is available for download from the internet.
The applicability of the criteria on benefit/risk consider-
ations was tested while the guidelines were being devel-
oped, using five case study examples. These included
products already on the market (a glass cleaning prod-
uct, PET bottles, awning fabric), products in develop-
ment (a textile cleaning product) and materials at the
very early stages of development (wind turbine rotor
blades made from materials containing CNT). All of the
case study examples provided useful insights as regards
the applicability and limitations of the list of criteria.
These were fed back into the subsequent stages of the
Issue Group’s work.
To illustrate what the results of a test might look like,
two of the five case study examples (PET bottles and
awning fabric) were worked up in full for publication
based on the most recent version of the list of criteria.
Work on the other examples revealed that, in terms of
enabling sound and comprehensive consideration of
benefit- and risk-related factors, the list of criteria was
of limited use in the case of products still in develop-
ment, where an established supply chain down to the
finished product does not yet exist (e.g. in the case of
the wind turbine rotor blades made from materials con-
taining CNT). The individual criteria still proved useful,
however, for precautionary evaluation of products
enabling a company to assess a product’s state of
development, drawing attention to potential risks and
prompting further testing (e.g. in the case of the textile
cleaning product).
It also became clear in this course of this work that the
set of criteria was only applicable to a limited extent in
the case of products for which a company had already
obtained a scientific risk evaluation (e.g. in the case of
the glass cleaning product). It was found that some of
the criteria required a re-examination of data which the
risk assessment had already provided. Potentially this
could give rise to false interpretations. The companies
concerned therefore decided against publication to pre-
vent misinterpretation. The environmental and con-
sumer associations were disappointed that the Report
now contained only two sample cases. It would have
been useful to have a larger number of sample cases to
test the applicability of the list of criteria.
Figure 15: Scanning electron microscope image of the surface of a fabrictreated with a nano-based material
2.3.3 Criteria for preliminary, integrated benefit-risk assessment of nanoproducts
The starting point of the assessment criteria is to char-
acterise the product by generating a product profile.
Akin to the characterisation of substances in Safety Data
Sheets, the user gathers together the available informa-
33
tion on the planned finished product, e.g. from the
Safety Data Sheet or other product information sources
(own information, information provided by suppliers).
In addition, a reference product manufactured without
the use of nanomaterials or nanotechnologies is used
for comparison. The product profile asks for informa-
tion on the following parameters:
Parameters concerning the nanoproduct:
Designation of the product and technical
functionality of the finished product
Specification of the functional unit
Function of the nanomaterial in the product
Reference product and rationale for its selection
Parameters concerning the nanomaterial used
Name of the nanomaterial and its manufacturer
Information on the value chain
Form factor, particle size and particle size
distribution
Surface functionalisation and coating
Information from the safety data sheet and
available scientific research studies
(e.g. on toxicity and ecotoxicity)
Other special features or characteristic properties
Figure 16: Testing for nanoclay migration from doped plastics
A multi-level Excel spreadsheet assists the user to
describe the benefits of the product in sustainability
terms and, where possible, to quantify this. The product
is then also graded according to various risk criteria.
Detailed sub-criteria were formulated for each of the
two areas. In both areas, benefit and risk aspects are
assessed throughout the entire product life cycle and
compared to the reference product (without nanotech-
nologies). The key criteria for assessing benefit and risk
aspects are presented in the simplified table below.
Companies could use guidelines like these as an early
warning system in their product development process.
At the same time, in keeping with the Five Principles of
the NanoKommission, the guidelines also suggest ways
of shaping communication and information on
34
Table 2: Comparison of potential benefit and risk aspects relating to nanoproducts
Potential benefit aspects Potential risk aspects
Benefits for the environment Risks for the environment
• Reduced resource use: energy• Reduced resource use: water• Reduced resource use: raw materials
• Volume used annually in the product• Probability of emissions• Measures to reduce emissions
• Prevention of greenhouse gas emissions• Reduced emissions of pollutants
• Probability of exposure affecting environmentalmedia: water, soil, air
• Reduced waste volume and hazard
Benefits for consumers Risks for consumers
• Products with improved functionality • Amount used in a product• Products with improved safety in use (including • Use by consumers
protection from disease) • Probability of emissions• Consumers benefit from improved cost-benefit ra- • Measures to reduce emissions
tio for products • Potential ways of exposure
Benefits for employees Risks for employees
• Advantages resulting from simpler or • Amount used in the workplace safer handling • Probability of emissions
• Health protection in the workplace • Measures to reduce emissions(risk management) • Testing effectiveness of measures
• Probability of exposure – presence of employees • Probability of exposure – measures to minimise
exposure• Probability of exposure – effectiveness of measures
Benefits for society Risks for society
• Lower costs for protecting health and the environ- • Potential external costs for society ment (health/welfare system and/or ecosystem)
• New skilled job opportunities, job security • Threat to peace within society• Better product performance; improved export • Incorrect use
opportunities, improved market position and • Risks to the national economycompetitive edge • Social impact of the product
Benefits for the company Risks for the company
• Building new markets, enhanced competitiveness • Loss of image• Improved product quality and performance • Financial/economic losses• Reduced costs, e.g. by optimising production • Uncertainty of long-term strategies;
processes risks of investment • Increased job and process safety
35
nanoproducts and show which information resources
are already available for this purpose and which need
to be generated. This could also help to improve stake-
holder dialogue.
2.3.4 Conclusions of the Issue Groups on preliminary, integrated benefit-riskassessment
Some segments of the Issue Groups advocate continuing
the work on preliminary, integrated benefit-risk assess-
ment.
It is recommended in particular that the criteria
for social and company benefit and risk aspects
should be further developed, as the Issue Group
was not able to debate these conclusively. It would
therefore be important to appoint a body or
organisation as soon as possible to take charge of
developing these areas further.
The present Excel spreadsheet is regarded as a
preliminary working document. Further develop-
ment of these areas could provide, for example, a
user-friendly, IT-based tool presenting benefit and
risk factors and, where appropriate, a basic assess-
ment of them. This could best be done in a proj-
ect-based framework; scientific research institu-
tions, for example, could develop the criteria fur-
ther, while weighting of the criteria or setting the
social context could be done in a stakeholder dia-
logue, if so desired.
Alongside more in-depth work on content, another
decisive factor for the success of any future instrument
for assessing benefit and risk aspects will be to ensure
close coordination of communication with the outside
world and with similar international projects, such as
the Swiss Precautionary Matrix. The following measures
are recommended to improve implementation:
To familiarise government departments and sec-
toral authorities with the use of the guidelines,
and to gather experience with their application;
where appropriate, this should feed back into the
continuing development process.
Once it has been developed further, to publicise
the instrument as a basic tool for assessing benefit
and risk aspects associated with nanoproducts and
to review measures and instruments that could be
used to create incentives for industry to apply the
guidelines. These could include: providing support
for assessing information and using it to decide on
options for action; providing opportunities for
users of the guidelines to exchange information
(workshop, interactive internet platform, etc.).
To introduce the integrated guidelines into the
international debate, for example discussions on
the Swiss Precautionary Matrix, the deliberations
on “Cooperation on Environmentally Sustainable
Use of Manufactured Nanomaterials” led by Sub
Group 9 (SG9) of the OECD Working Party on
Manufactured Nanomaterials, or the nano dia-
logue at EU level.
As a prerequisite for continued development of the inte-
grated guidelines for benefit and risk assessment, atten-
tion needs to be given to further refining their content.
The Issue Group therefore suggests:
Integrating into the guidelines the findings of the
project “Sustainability check for nanoproducts”,
currently being conducted by the Institute of
Applied Ecology on behalf of the UBA.
The in-depth work on preliminary risk assessment car-
ried out in a second Issue Group of the NanoKommission
should also be integrated into the guidelines. The next
section covers the findings of this second Issue Group.
2.3.5 Elaboration of criteria for preliminaryassessment of the impact of nanomateri-als on human health and the environment
The work of the second Issue Group builds on the
matrix of criteria indicating “concern” and “no cause
for concern” developed by the first NanoKommission.
Based on this, a list of criteria was established in the
current dialogue phase which includes guidance for
preliminary assessment of nanomaterials in terms of
their impact on people and on the environment. While
the first Issue Group addressed products, the second
36
Issue Group focused on materials. The group has creat-
ed an important basis for a preliminary assessment of
nanomaterials. In cases where risk assessment is
required by law or where comprehensive voluntary risk
assessment is in place, these replace any preliminary
assessment based on the present criteria. The list of
criteria is aimed at the informed user (as opposed to lay
people or scientists). The criteria are applicable to all
engineered nanomaterials, in other words both to
nanomaterials in research and development and to
those already in use or available on the market. They
can also be applied to free nanomaterials, including
their aggregates and agglomerates,29 and to products
containing bound nanomaterials.30
Challenges for the Issue Group:
1. To describe scientifically accurate, and yet simple
and practicable parameters for identifying the
need for precautionary measures / criteria for
concern and no cause for concern for uses of
nanomaterials.
2. To elaborate simple assessment criteria that
would also enable informed users to make an
initial assessment.
Due to the intended target group it seemed expedi-
ent to avoid developing criteria that could only be
applied using complex measuring methods, going
beyond the basic information generally required.
3. To take into account all the criteria established
in the first dialogue phase.
In the first dialogue phase, no emphasis was
placed on developing a simple assessment tool. To
avoid losing any of the criteria from the first dia-
logue phase, criteria that could not be met with-
out specialist knowledge or considerable research
effort were bundled together under the heading
“scientific risk evaluation and research”.
4. To establish benchmarks for assessment.
When developing an assessment framework the
Group did not favour weighting the criteria or plac-
ing them in hierarchical order; this was deemed
neither necessary nor useful. Weighting of the cri-
teria, in the Group’s view, was in any case not possi-
ble at the abstract level, because the importance of
particular criteria might increase or decrease
depending on the application in question. On the
other hand, however, simply grouping the criteria
together would mean a loss of information and
could result in errors.
Over the course of the four scheduled dialogue sessions
and several additional consultations, the criteria were
grouped into four blocks: probability of exposure, physi-
co-chemical properties, behaviour in the environment,
and toxicology and ecotoxicology.
Each of the criteria is formulated as a guiding question
requiring a “yes” or “no” answer. Depending on the cri-
terion in question, a “yes” or “no” response leads to one
of the following categories: “No immediate need for
precautionary measures / No cause for concern”, or
“Further consideration / Need for precautionary meas-
ures / Cause for concern”. In the absence of information
to answer the question, the response “data gap” can be
given. It is envisaged that the user will check and
respond to all of the criteria.
Each criterion is assigned a letter denoting the protec-
tion target(s) for which it is relevant (U = environment
and people (Umwelt und Mensch), A = Employees
(Arbeitnehmer), V = Consumers (Verbraucher)). This is
useful for evaluating the results for each individual pro-
tection target. In some cases the criteria are accompa-
nied by additional notes, e.g. relating to testing proce-
dures. In the last column of the table the user is asked
to state the basis for his/her decision (e.g. information
source) to make this clear to third parties if needed.
The structure of the table is shown below based on the
example of the criterion “Production volume” in the
block “Probability of exposure”.
The table for “Production volume” would then be
followed by a list of all the other questions and
explanations for each of the blocks of criteria:
“Probability of exposure”, “Physico-chemical proper-
29 This includes nanomaterials which may foreseeably occur during use, for example via special spray heads in aerosol sprays. Each term used is explained in the guidelines.
30 It is also recommended to assess nanomaterials which do not fall within the size range stipulated in the working definition, as this definition is a preliminary one and in other contexts other (e.g. larger) sizes may be relevant.
37
ties”, “Behaviour in the environment”, and
“Toxicology and ecotoxicology”.
The structure shown in the table above is identical
for all of the blocks and focuses on the following key
questions:
Probability of exposure
Is the volume of nanomaterial
manufactured > 100 kg/year?
Is the material handled only in closed facilities?
Is the material easily released?
(dust, aerosol formation, waste water)
Is the material used or intended for use in a
consumer product?
Is the material released intentionally into the
environment? (e.g. groundwater remediation,
agricultural applications)
Is the nanomaterial easily released? (e.g. dust,
aerosol formation, in water, by abrasion)
Is the nanomaterial easily released during product
disposal/recycling? (e.g. dust, aerosol formation,
water, matrix destruction)
Physico-chemical properties
Does the nanomaterial have a fibre, tube or
rod-like morphology?
Is its surface > 6/100 nm-1
Is the nanomaterial known to be chemically,
catalytically or biologically reactive or is the mate-
Table 3: Format of the list of criteria based on the example “Production volume”
CriterionProtec-tiontarget
Explanation
Further consideration /Need for precautionarymeasures / Cause forconcern
No immediateneed for pre-cautionarymeasures / No cause forconcern
Datagap
Documentation / basisfor decision
Productionvolume
AVU Is the volume of nanomaterial manufactured > 100 kg/year?
Yes
No
Cannot an-swer / donot know
38
rial manufactured specifically to produce reactive
properties?
Is the material readily soluble in water, resulting
in loss of its nanostructure?
According to the parameters for dust formation,
can the material’s propensity to generate dust be
classified as “minimal”?
Behaviour in the environment
Is the nanomaterial completely degradable?
Is the nanomaterial permanently embedded in
a stable matrix and hence cannot be released or
moved into the environment?
Toxicology / ecotoxicology
At the present time there are no clearly accepted crite-
ria indicating no cause for concern in toxicological and
ecotoxicological terms. It is therefore not currently pos-
sible to make a preliminary assessment in this regard.
Full scientific risk evaluation is required. According to
some of the Issue Group representatives this clearly lim-
its the applicability of the preliminary assessment tool
in general. For the purposes of assessment, however, all
available information such as information from public
databases and suppliers should be taken into account as
far as possible.
Are there any indications of toxic effects that
are relevant for humans?
Are there any indications of ecotoxic effects that
are relevant for the environment?
If the answer is yes to either or both of these questions,
then human and/or environmental exposure should be
investigated more closely. This should take place within
the framework of a scientific risk evaluation.
Full details of the criteria and explanations of the infor-
mation required in the responses are available as a
downloadable file on the internet. The list of criteria
can also be downloaded as an Excel spreadsheet.
2.3.6 Evaluation of the criteria table
The criteria table is aimed at raising users’ awareness of
potential causes for concern and factors giving no cause
for concern, as well as highlighting gaps in the users’
information. If there are data gaps for many criteria in
the table, this is indicative of a significant lack of
knowledge with regard to the nanomaterial in question
and its uses. More detailed examination of the relevant
criteria is therefore needed before any steps can be tak-
en to place the material on the market, for example.
The fewer the data gaps identified and hence the
greater the number of criteria to which a response is
given, the more comprehensive and meaningful the
assessment. The data are not aggregated and no quanti-
tative indicators (e.g. risk index, etc.) are defined, as this
would result in a loss of information. At the end of the
assessment process, emphasis is given instead to inter-
preting the significance of each answer, and this can be
done either through in-house discussions or in dialogue
with experts, other users or stakeholders.
Evaluation takes the form of a table in which the num-
ber of similar answers for each “block” of criteria is giv-
en and differentiated according to protected resources.
These combined responses are then calculated as a ratio
of the total number of responses. Initial interpreting
aids include:
The proportion of responses in the data gap field
within each block gives an indication of the extent
to which the user of the criteria lacks knowledge
concerning the relevant use of the nanomaterial /
nanoproduct. It can therefore be used as an
indicator of uncertainty in the assessment.
The share of responses in the field “Further con-
sideration / Need for precautionary measures /
Cause for concern” within a given block indicates
that additional or more detailed information
needs to be generated in order to examine the cri-
teria in question in a more differentiated manner.
The share of responses in the “No immediate need
for precautionary measures / No cause for con-
cern” field within a given block provides an indi-
cation of whether and to what extent suspicions
regarding potential impacts arising from the use
of the nanomaterial in question can be allayed.
39
Here too, however, detailed consideration
of the specific use is indispensible in order
to take account of prevailing differences in
the weighting of criteria.
A large share of responses in the “No imme-
diate need for precautionary measures / No
cause for concern” field in the "Probability
of exposure" block (minimal probability of
exposure) can be considered to indicate
(increased) likelihood that there is no cause
for concern, since lack of exposure means
that no effects are to be expected. This
trend should likewise be interpreted with
caution, taking into account the different
weightings given to criteria.
If the user of the criteria identifies potential
grounds for concern regarding the use of a
nanomaterial, s/he could consider first of all
discussing and verifying the result of his/her
assessment with expert help. If the assessment
indicates “Further consideration / Need for
precautionary measures / Cause for concern”,
options for conducting scientific risk evaluation
of (this use of) the nanomaterial should be
explored. In the event of a concern arising with
regard to the environment, but no grounds for
concern are identified relating to employees and
consumers for the use in question of the nanomaterials,
the scientific risk evaluation can include a “targeted
risk assessment” focusing on the specific protection
target.
Figure 17: Light microscopy examination of a fibre composite component
2.3.7 Conclusions of the Issue Group on elaboration of criteria for preliminaryassessment of nanomaterials
The criteria developed by the Issue Group reflect the
debate conducted by the group within a narrow time-
frame. To ensure that this set of criteria can be success-
fully established as a simple tool for initial assessment
of the potential impact of nanomaterials, it may be
helpful to consider the following:
Experience relating to application of the criteria
in practice should be gathered and taken into
account when developing criteria further.
The work carried out on the list of criteria should,
if possible, be continued in cooperation with
those working on the Swiss Precautionary Matrix
and in relation to the issues outlined above.
The criteria should also be incorporated into relat-
ed international dialogue processes or projects
and studies aimed at developing instruments for
assessing nanomaterials.
Users of the criteria should be able to draw on
experts to help with interpreting the results and,
where relevant, identifying information or
appropriate risk management measures.
Exchange of experience among users of the
criteria would be useful.
Subject to successful practical testing, the criteria
could be incorporated into a broader context. For
40
example, this tool could be applied to the context
of implementing the principles for the responsible
use of nanomaterials,31 where it could be used
particularly to improve risk management and
ensure transparency in communication.
The Issue Group recommends:
Establishing an advisory service at the level of a
federal agency. An advisory service could gather
experiences of using the criteria and harness
these to develop the criteria further. In addition, it
could assist users of the criteria to interpret the
results and, where necessary, to identify relevant
information and develop appropriate risk manage-
ment measures. Another component of the adviso-
ry service’s remit could be to organise an
exchange of experience among criteria users.
Figure 18: Highly entangled aggregation of manufactured carbon nanotubes
31 See Report of the NanoKommission for the first dialogue phase and thereport by Issue Group 1 in the present report in section 2.3.4
41
2.4 Regulation of nanomaterials
2.4.1 Remit of the Issue Group on regulation
Early in its second dialogue phase the NanoKommis-
sion assigned this Issue Group the task of analysing
the basic issues and options for regulation based on
the precautionary principle and, where possible, to
make recommendations to the Federal Government
on regulation of nanomaterials. The Group’s report
covers the international debate on a definition, pres-
ents explanations of the precautionary principle, com-
piles and comments on the existing provisions and
discusses a variety of different regulatory instruments.
Its recommendations were aimed at the Federal Govern-
ment not only as the national regulatory authority, but
also as a stakeholder in the context of EU regulatory
activities. The 70-page report is available on the website
of the BMU (www.bmu.de/nanokommission/). Stake-
holders from the scientific community, various federal
ministries and higher federal authorities, from industry
and NGOs used their four sessions and subsequent writ-
ten commentaries to generate a continuous and con-
structive dialogue and exchange of information and
opinion. The following section presents the key findings
and recommendations of the Group.
2.4.2 Foundations of the debate on regulation
The regulation group addressed the following main
issues:
As regards the issues of a definition, a nanoprod-
uct register and labelling, no consensus was
reached within the Group to enable common rec-
ommendations to be made. As the state of debate
nevertheless needed to be presented to the Feder-
al Government, tables were produced showing
Group members’ opinions on these issues.
The precautionary principle, as a general princi-
ple of law, was elucidated according to the deci-
sion-making body concerned, with distinctions
being drawn between legislation, administration
and jurisdiction. The precautionary principle lays
down a duty of protection (hazard control / risk
prevention) of human health and life and the
environment and thereby also creates a frame-
work for dealing with gaps in knowledge (see next
section).
Concerning a number of regulatory provisions,
such as REACH, and in areas such as occupational
health and safety, food law, cosmetics, biocidal
products and plant protection products, the Group
was able to arrive at a common interpretation of
what is required, and to formulate specific recom-
mendations, which are presented below.
As regards existing provisions, the report sets out
both positive aspects and shortcomings identified
on a consensual basis by the Group.
In addition, positions and demands of stakehold-
ers that went beyond the consensus position with-
in the Issue Group are presented transparently.
Debate within the Group was heated on matters
relating to a general authorisation procedure
(with the aid of positive lists), individual authorisa-
tion procedures, labelling, and the issue of a prod-
uct register. As the focus of debate in this Group
was on assessing the regulatory provisions them-
selves, it was not possible to deal with down-
stream regulatory instruments in sufficient depth.
Figure 19: Carbon nanofibres – test samples under the scanning electronmicroscope
The precautionary principle as a guiding concept
In situations where there is uncertainty and/or a lack of
knowledge regarding the consequences of new tech-
42
nologies, substances, products or production processes,
the question arises as to whether the state can legiti-
mately intervene to protect the environment and
human health. The precautionary principle, given con-
crete form in relation to the environment by the Euro-
pean Commission in 2000 (COM (2000) 1 final), provides
guidance here that is also relevant in legal terms. The
precautionary principle is firmly established today as a
general principle of law as a component of the constitu-
tional goal of environmental protection set out in the
Basic Law for the Federal Republic of Germany,32 of the
corresponding aims of the European Union33 and as a
component of the principle of sustainable development
in international law (c.f. Principle 15 of the Rio Declara-
tion on Environment and Development).
In situations where – as is often the case with innova-
tions – there is a lack of reliable scientific evidence
establishing a connection (causality) between a technol-
ogy, substance, product or production process and an
adverse effect, it is not possible to assume that there is
sufficient probability of an adverse effect occurring.
Sufficient probability in this context refers to the sort
required (in the legal sense) for conventional hazard
control. Against this background, the precautionary
principle may be applied particularly in cases where
there is a need for action because of a potential hazard
to human health or to the environment, but insufficient
scientific information is available to show sufficient
probability of an actual hazard.
This means that for the purposes of risk prevention it is
legitimate for the state to take action in the form of
precautionary measures if there is merely an abstract
possibility of harm occurring to people or to the envi-
ronment. As a result, the point at which intervention
becomes permissible is brought forward, enabling the
government to take action before the hazard threshold
is reached.
In order to avoid unwarranted – and legally question-
able – application of the precautionary principle, the
grounds for invoking the precautionary principle must
be established. To do this, a distinction needs to be
drawn between two consecutive steps: risk identifica-
tion (also referred to as risk estimation or scientific risk
assessment) and normative risk assessment. Where it is
not possible to identify clearly the grounds for recourse
to the precautionary principle, the burden of proof is
reversed, enabling the legislator to make provisions on
the basis of the precautionary principle. Responsibility
for rebutting the presumption of hazardousness made
by the legislator then falls to the originator of the risk.
If action is deemed appropriate, a wide range of
options is available. While upholding the principle of
economic freedom that ensures opportunities for inno-
vation, the choice of action must be guided by the
abstract level of concern, which in turn needs to take
into account the potential extent of any adverse effects.
In this regard it can be helpful to work with formulae
along the lines of “the more/less... the better/worse”,
based on the criteria indicating concern or no cause for
concern developed by the NanoKommission in its first
dialogue phase. Legally binding measures that might
come into consideration range from rules concerning
provision of information, reporting obligations, and
labelling requirements, to rules relating to liability
(including liability regardless of fault) and mandatory
prior authorisation requirements (prohibition of activi-
ties unless authorised), which may also be based on a
rebuttable presumption of hazardousness with the bur-
den of proof resting on the risk originator. Other meas-
ures that might be considered include research fund-
ing, public information campaigns on the potential
negative consequences of a product or process, or mak-
ing recommendations.34
The precautionary principle therefore plays an impor-
tant role in the introduction and use of nanotechnolo-
gies, especially if knowledge is largely lacking with
regard to any hazards they may pose. The precaution-
ary principle allows the opportunities and risks posed
by technologies to be systematically identified and
assessed. Decisions concerning regulation can thus be
prepared in such a way as to ensure that the develop-
ment of these technologies is supported while limiting
potential risks.
32 Article 20a of the Basic Law for the Federal Republic of Germany 33 Cf. aim of the European Union set out in Article 191 (2), 2nd sentence of the Treaty on the Functioning of the European Union (TFEU)34 Cf. COM (2000) 1 final, especially p. 4
43
2.4.3 Recommendations on regulation
This section summarises the recommendations of the
Issue Group to the Federal Government alongside the
comments of the NanoKommission.
REACH
In the opinion of the Issue Group, when the REACH
Regulation concerning the registration, evaluation,
authorisation and restriction of chemicals comes up
for revision in 2012, some of its provisions should be
amended to include the specific requirements of
nanomaterials. In addition, the REACH Annexes and
the ECHA Guidance documents (guidelines for imple-
mentation) also need to be brought up to date and
amended in a timely manner in the light of new
research findings concerning nanomaterials.
The Issue Group views the following as priorities:
Introduction of a definition enabling clear iden-
tification of nanomaterials and clarification of
the definition of “substance” in the REACH
Regulation
Adjustment of requirements for provision of
information on nanoscale substances
Further review and, where appropriate, adjust-
ment of testing methods and strategies, e.g. in
the OECD context
Provisions to incorporate nano-specific
information into Safety Data Sheets
Adjustment of transitional deadlines for the
registration of nanoscale substances
If necessary, lowering of the tonnage thresholds
for a nano-specific assessment programme and
chemical safety reports based on it.
No consensus was reached on:
Treating nanomaterials as new substances (non-
phase-in substances) as a matter of principle
Lowering the 0.1% threshold in the provisions on
nanomaterials in articles
Establishing criteria that enable differentiation of
nanomaterials which have the same chemical
composition but different properties and may
need to be registered as separate substances
The possibility of excluding the nanoforms of sub-
stances listed in Annex IV and V from the
provisions on exemptions
Considering the downstream user who produces
a nanosubstance from the bulk form of a material
to be the manufacturer within the meaning of
REACH, where appropriate.
Please refer to the report of the Issue Group for more
detailed information on specific opinions.
Figure 20: Measuring out fine dusts and nanoparticles in a glove box
Occupational health and safety
The German Hazardous Substances Ordinance
(Gefahrstoffverordnung) and the Technical Rules for
Hazardous Substances governing its implementation in
practice (Technische Regeln für Gefahrstoffe – TRGS)
form the bedrock of national regulation of nanomateri-
als in relation to occupational health and safety. Com-
plementing these are guidance documents produced by
the Federal Institute for Occupational Safety and Health
(BAuA) and the German Chemical Industry Association
(VCI). Minimisation of exposure is a fundamental
44
requirement in all of these instruments. Another
requirement, however, is that sufficient information
must be available on the properties of a substance to
enable a hazard assessment to be carried out and to
provide the basis for planning appropriate protective
measures. The Issue Group was unable to reach a con-
sensus on whether additional provisions need to be
introduced in Germany at the level of an Ordinance.
As regards a general limit for biopersistent nanoparticu-
late dusts, the group agreed unanimously that the avail-
able scientific data should be reviewed with a view to
establishing whether setting such a limit is feasible or
advisable. As a specific step, the Group suggests that
the preliminary work done by the Federal Institute for
Occupational Safety and Health (BAuA) should be made
available to Sub-Committee III of the German Govern-
ment’s Committee on Hazardous Substances
(Ausschuss für Gefahrstoffe – AGS). On precautionary
grounds, the Group also recommends putting in place
transitional provisions until sufficient data are avail-
able. The Group continues to support efforts to review
the introduction of limits for nanodusts and establish
what those limits should be.
The Group perceives a need for action to develop
procedures for testing nanomaterials and establish
specific exposure data.
The Cosmetics Regulation
The new EU Regulation (EC) No 1223/2009 on cosmetic
products first of all stipulates that only safe products
may be placed on the market. Prior to being placed on
the market every cosmetic product must therefore
undergo a qualified safety assessment. The provisions of
the new Regulation also apply to cosmetics containing
nanoparticulate ingredients, and are set to come into
force for the most part in 2013. The European Commis-
sion must be notified in future regarding the use of cer-
tain nanomaterials in cosmetics. Where there is any
doubt as to safety, the Commission can require safety
data to be submitted. Substances intended for use as
preservatives, colourants or UV filters must undergo
separate authorisation for inclusion in the relevant
positive list of permitted substances. The Cosmetics Reg-
ulation also introduces the requirement to append the
word “(nano)” to the substance name on the product
ingredients list. Specific requirements for nanomaterials
are based on the definition of nanomaterials estab-
lished by the EU’s Scientific Committee on Consumer
Products (SCCP). It is also noted that this definition
should be adapted as and when a new definition is
agreed at international level.
All in all, the Issue Group thought that the new Cosmet-
ics Regulation provides a good basis for regulating
nanomaterials. Some Group members, however, were
critical of:
the relatively narrow definition of nanomaterials,
which excludes soluble nanomaterials and materi-
als with size-dependent properties which are larg-
er than 100 nm
the fact that nanomaterials are not subject to an
authorisation requirement unless they are intend-
ed for use in products for which a positive list of
permitted substances exists (UV-filters, colourants
and preservatives)
the fact that the Regulation does not come into
effect until 2013, whereas a multitude of products
are already on the market.
Food Law
Three regulatory areas relating to food law were dis-
cussed in the Issue Group: novel food, additives, and
food contact materials.
As regards the consultations on the revision of the
Novel Food Regulation (Regulation (EC) No 258/97 was
undergoing revision in Brussels in December 2010) the
Group basically welcomed increasing the specificity of
the existing provisions with regard to the use of nano-
materials in food. However, no agreement was reached
on the required scope of the relevant provisions. It was
also noted that there is a lack of clarity as regards areas
in which nanomaterials are already being used in
foods. Unsurprisingly, discussions on these issues were
intense, reflecting the fact that this area has a direct
bearing on consumers and is therefore politically highly
sensitive. (See also the full report of the Group for tables
showing the stakeholder positions.)
45
Applications of nanoscale ingredients for technological
purposes such as preservatives, flow aids or colourings
fall within the scope of Regulation (EC) No 1333/2008
on food additives. The 2008 Regulation makes provision
for re-evaluation of safety and, where appropriate,
re-authorisation of food additives if they are used in a
form that differs from the form previously used and
assessed by the relevant authority. In principle the Reg-
ulation contains no provisions concerning specific test-
ing procedures for nanomaterials – or for food additives
not used in nanoparticulate form. Provision for specific
labelling of nanoscale ingredients is also absent.
Specific testing methods are stipulated in the course of
the case-by-case authorisation procedure, along with
conditions for use and labelling requirements.
Discussions on the Regulation on food contact materials
((EC) No 1935/2004) focused on packaging that acts as a
barrier, or has coatings to block out liquids, gases or UV
light, packaging materials with built-in antibacterial
properties or packaging materials with an indicator
function that can sense and signal if a food is spoiled.
The discussions also covered nanomaterials used to
modify the function of surfaces in food manufacture
(e.g. on conveyer belts, transport containers, or mixers)
to achieve a variety of effects, such as dirt-repellency
(“lotus effect”) or antibacterial surfaces, energy efficien-
cy, or improved adhesion properties. Regulation (EC)
No 1935/2004 regulates the safe and appropriate use of
food contact materials.
The Issue Group considers the current Regulations on
novel foods, food additives and food contact materials,
which were the focus of its discussions, to be basically
adequate.
Some of the Group’s members considered the envisaged
authorisation procedures and safety assessments to be
adequate. Case-by-case authorisation, they felt, provided
sufficient scope for authorities to stipulate specific test-
ing requirements where necessary, impose restrictions
on the use of a substance, or lay down labelling require-
ments if there were reasonable grounds for doing so.
Other Group members, meanwhile, felt that fundamen-
tal requirements were not met by the existing legisla-
tion, such as inclusion of a definition of nanomaterials
or nano-specific testing requirements for official autho-
risation procedures or for appropriate safety assessment
by manufacturers. They also recommend introducing a
general labelling requirement instead of labelling on a
case-by-case basis only.
During the reporting period of the NanoKommission
and its Issue Groups, Guidelines on the assessment of
nanoscale substances by the European Food Safety
Agency (EFSA) were being drafted for all three regulato-
ry areas. The positions set out here on regulation relate
to the state of debate as of August 2010.
Figure 21: Plastic with nanoclay gas barrier
Biocidal and plant protection products
In summer 2011 a new European Regulation on the
placing on the market of plant protection products
((EC) No 1107/2009 – Plant Protection Regulation) will
replace the current Plant Protection Directive. The exist-
ing Biocidal Products Directive is currently being recast
as a Regulation. Applications of nanomaterials in these
areas range from materials such as nanosilver, which
has biocidal properties, to plant protection products
encased in nanomaterials to enable dosed release.
46
Current European law35 contains no separate provisions
concerning biocidal products and plant protection
products which contain substances at the nanoscale.
For the new Regulation on plant protection prod-
ucts, too, in the interests of ensuring harmonisa-
tion of the different provisions the Group recom-
mends establishing a uniform definition of nano-
materials and supporting efforts to this end. To
promote harmonisation, the properties of sub-
stances should be identified in the manner
prescribed under REACH.
The Group recommends carrying out a review to
ascertain whether current guidelines on testing
adequately take into account the specific proper-
ties of nanomaterials, or whether they need to be
adapted. Established procedures for testing formu-
lations and modifications to formulations should
also be reviewed. Important preliminary work in
this area
is currently under way in the OECD.
It is recommended that due attention be paid to
the specific uses of plant protection products and
biocidal products to take into account any risks
specifically associated with the use or application
of nanosubstances over and above the general
substance assessment.
Recommendations on product registers
Product registers can serve a wide range of different
purposes, and may therefore vary widely in many
regards, such as responsibility for collecting and pro-
cessing information, access for different parties, nature
of information contained in them and the purpose for
which they are intended. Accordingly, various types of
product register were discussed. Possible objectives that
could be served by a nanoproduct register include:
to create transparency with regard to which
products contain what kind of nanomaterials;
to enable traceability of nanomaterials with a
view to assisting authorities, manufacturers and
distributors of nanoproducts to take appropriate
risk management measures (e.g. product recall)
to guarantee freedom of choice for consumers, in
other words to give them the option of buying
products with or without nanomaterials.
Therefore, different levels of disclosing information
could be considered for different types of register. Bear-
ing in mind the need to protect the intellectual proper-
ty of manufacturers or distributors, the Group discussed
several options, including: a register in which all the
information provided is publicly accessible; a register
in which only certain information is publicly accessible;
or alternatively, which produces a publicly accessible
annual report with information on the register’s
content. No common position was arrived at within
the Group on this issue.
The information contained in a product register
depends on the purpose of the register and its accessi-
bility (whether it is a public database). Some stakehold-
ers advocated including the following information:
Product name and trade name
Manufacturer / distributor
Nanomaterials used in the product
(substance identity)
Uses
Guidelines on safe use / risks of the product
(for occupational health and safety, analogous to
Safety Data Sheet)
Link to the corresponding substance in the REACH
database.
In the course of the discussions it was pointed out that
REACH, the Novel Food Regulation, the Cosmetics
Regulation and the Regulations on biocidal and plant
protection products all require registration, especially
for authorisation of substances and articles. Industry
representatives consider these provisions, and the infor-
35 The Group considered the EU Biocidal Products Directive, the new Regulation on biocidal products currently in preparation, and the EU Regulationon Plant Protection Products
mation they provide to the authorities, to be adequate
and reject the idea of introducing a general nanoprod-
uct register. The environmental and consumer organisa-
tions emphasised that existing provisions do not ade-
quately meet the interests of consumers as regards
information on nanoproducts. Moreover, they pointed
out, current registration procedures (with the exception
of notification under the provisions of the Regulations
on Biocidal Products and on Cosmetics) make no dis-
tinction between materials in the nanoform and those
in larger form. As a result, public bodies have no infor-
mation as to whether registered substances are used in
the nanoform.
foods. The Commission has responded positively in prin-
ciple to the amendment proposed by Parliament in this
regard.
The proposal was also taken up by the Belgian presiden-
cy of the Council in the Council debate on the proposal
for a Regulation. According to this proposal, the suffix
“(nano)” should be appended to ingredient listings for
any food ingredient present in the form of a manufac-
tured nanomaterial. Consultations on this matter have
yet to be concluded.
All stakeholders consider it essential that public
bodies (monitoring bodies, poisons information
centres, emergency centres, etc.) should have
access to the information contained in product
registers. If safety-related information cannot be
made available to the public in a specific case,
reasons for this must be given.
Labelling of consumer products
Discussions on product labelling focused exclusively on
labelling of consumer products36 in which nanomateri-
als are not bound within a stable matrix.
At present, only the Cosmetics Regulation makes explic-
it provision for labelling of nanomaterials in products.
According to the position of the Council on the first
reading of the draft proposal for a revised Novel Food
Regulation of March 2010, specific labelling obligations
may be stipulated in the authorisation of a novel food.
The European Parliament, meanwhile, advocates a gen-
eral labelling requirement for the use of nanomaterials
in foods and has reaffirmed its position on this matter
in the second reading. Consultations have not yet been
concluded (as of this writing in December 2010). The
conciliation procedure is due to begin in the near
future. At the first reading of the proposal for a Regula-
tion on the provision of food information to consumers,
the European Parliament voted in favour of introducing
a general labelling requirement for nanomaterials in
Introduction of nano-specific labelling is also under
discussion for the new legislation on biocidal products:
Opinions varied widely within the Group as
regards cases where a labelling obligation for
nanomaterials might be expedient. Positions
concerning which products should be subject to
labelling ranged from “all consumer products and
applications in the open environment” to “cases
where potential grounds for concern cannot
be ruled out”, “products that have hazardous
properties”, and “voluntary labelling only”.
In the interests of ensuring freedom of choice, some
stakeholders favoured binding provisions as they ques-
tioned the effectiveness of voluntary labelling. Others
are of the opinion that product safety is guaranteed by
the German Equipment and Product Safety Act (Geräte-
und Produktsicherheitsgesetz) and by authorisation
procedures. Therefore they stated that compulsory
labelling of products which have no hazardous
properties is superfluous.
Advocates of binding provisions want these to apply to
authorised products too, not as a warning but as infor-
mation for consumers. Opponents of compulsory prod-
uct labelling point to existing labelling requirements
for products with hazardous properties (e.g. CLP Regula-
tion).
36 This refers mainly to products that are used frequently and which come into especially close contact with the human body, or which are used inthe open environment. Hence, for example, the discussion does not cover computer components or individual vehicle parts containing nanomateri-als.
47
48
Figure 22: OLEDS
2.5 “Sustainable Nanotechnologies –Green Nano”: A shared paradigm
2.5.1 Remit of the Working Group on developinga shared paradigm
One of the primary issues of the NanoKommission is the
question: what opportunities are there in our society for
developing a culture of innovation that upholds the prin-
ciple of sustainability and the precautionary principle in
an area of technology such as nanotechnology? In an
innovation process, a shared paradigm (Leitbild) can pro-
vide useful guidance, reduce complexity and provide
structures. It describes the socially desirable aspects of a
technology and links this with what is feasible in prac-
tice. Establishing a shared paradigm for nanotechnolo-
gies can help to bridge uncertainties regarding potential
benefits and risks and the potential success or failure of
innovations – uncertainties that represent some of the
most fundamental obstacles to innovation.
The task of developing a shared paradigm that enjoys
broad social acceptance can only be carried out by
means of dialogue. The NanoKommission therefore set
up a Working Group in 2009 to address issues concern-
ing a shared paradigm for sustainability in the field of
nanotechnologies and to specify requirements and
criteria that need to be taken into account when
designing these technologies. The Working Group on
“Sustainable Nanotechnologies – Green Nano” held two
sessions to debate the question of what such a para-
digm would mean in concrete terms and what “design
principles” would be needed to implement technology
and product design based on it.
In the context of the dialogue forum held as an interim
review of the NanoKommission’s work (Zwischenbilanz
der NanoKommission) in early 2010, a shared paradigm
for technology development and conceptions for broad
social debate about this paradigm were presented. In
addition, members of the Working Group took part in
a conference on “Green Technologies” organised by the
Protestant Academy in Schwerte, holding discussions
with experts and lay people.37 Drawing on previous
experience with developing technology-related
templates, notably “Nachhaltige Chemie” (Green Chem-
istry), adopted in Germany as a result of concerted
efforts by the Federal Environment Agency, the German
Chemical Society (GdCH) and enterprises in the chemi-
cal industry, the Working Group produced a discussion
paper on a shared paradigm for sustainable nanotech-
nologies entitled “Considerations for sustainable design
of nanotechnologies” (Aspekte einer nachhaltigen
Gestaltung von Nanotechnologien).
2.5.2 Key discussion points for developing ashared paradigm
Today “sustainability” is widely considered to be the key
principle for ensuring a viable future for society. Nan-
otechnologies
open up inter-
esting opportu-
nities for more
sustainable eco-
nomic develop-
ment, even
though many
developments
are still in their
infancy and
hence the direc-
tion in which
these technolo-
gies will actually
evolve often Figure 23: "Waterplay“, fibres made from cellulose acetate and silicon dioxide, Philipps University Marburg, Department of Chemistry
37 For more information [in German] see:http://www.kircheundgesellschaft.de/akademie/dokumentation.htm
49
remains unclear. With an eye to sustainability objec-
tives, developing a shared paradigm could prove useful
by way of a “technology push”, in other words targeting
support to particular applications and giving priority to
the pursuit of innovations in fields that society consid-
ers desirable. The aim of exerting influence in this way
is twofold: to steer the development of nanotechnolo-
gies in the direction of sustainable applications (e.g.
reducing pressures on the environment and protecting
resources), but also to foster sustainability in the design
of the technologies themselves (Green Nano).
The primary target audience for feedback processes on
the design of sustainable nanotechnology development
comprises those engaged in basic research, in research
promotion and funding programmes (e.g. the Federal
Government’s High-Tech Strategy), in strategic corpo-
rate development, in company research and develop-
ment departments, and in stakeholder organisations,
especially those concerned with environmental and
consumer protection, trade unions and churches/acade-
mies (multipliers). The groups also need to be involved
in an ongoing feedback process concerning the design
principles suggested here. In terms of economic players,
the focus is primarily on companies engaged in
research, technology developers and manufacturing
enterprises. Downstream user industries, too, exert
considerable influence on upstream developments.
The design of nano-based processes, products and nano-
materials on the basis of the shared paradigm of
“Green Nano” – as a responsible, voluntary approach to
sustainable technology development (as opposed to a
regulatory approach) – should gain more attention
than in the past. Lest there be any misunderstanding:
principles of design are not an alternative to the neces-
sary regulatory risk management measures. They
should be seen instead as one element in a broader
effort to harness all available means to foster sustain-
able technology development and risk management
based on the precautionary principle.
Dialogue on shared paradigms is launched in a very
early stage of the innovation process, similar to a
process of preliminary risk assessment with the aid of
criteria for concern and no cause for concern. As the
dialogue focuses both on minimising risks and on
exploiting potential benefits, it brings together the,
often separate, debates on risks and benefits at the very
early stages of innovation.
Figure 24: Water drops on a lotus leaf
Which paradigm? What do “sustainable” and “green” actually mean?
The design principles presented below relate to the goal
of developing “sustainable nanotechnologies” (or
“green nano” in international parlance), by which we
mean explicitly taking into account environmental,
health and safety considerations.
The paradigm of “sustainable nanotechnologies”
encompasses a rather broad spectrum of options, rang-
ing from emissions reduction and environmental reme-
diation measures at one end of the scale to biomimetics
at the other. The goal is not only to minimise and pre-
50
vent adverse effects (“design for safety”), but also to
bring about positive benefits for human health and the
environment (“benign by design”38).
The design principles of the “Green Nano” paradigm
outlined below are subdivided into four main areas (see
Figure 26): Biomimetics, Minimum Risk, Resource Effi-
ciency, and Energy and Environmental Technologies,
with the innovation steps depicted in the Figure below
being generally expected to widen incrementally from
bottom left to upper right. Explanations and examples
relating to the Figure are given in the report of the
Working Group, available as a downloadable document
on the BMU website (www.bmu.de/nanokommission/).
The design principles should not, of course be
(mis)understood as rules. They are goals, or guides for
reflection. Tensions are bound to arise between the
requirements of different design principles; there may
even be contradictions. Using the design principles to
implement the overall aims is therefore part of a broad
and complex optimisation process.
Limits of sustainable design
At present, most innovations in the nanotechnology
field remain technology-driven. Innovation processes
are largely determined by new technological possibili-
ties. Moreover, many innovation processes are still at an
embryonic stage of development. This of course limits
their scope just as much as the fact that very little is
known at present about the potential benefits and risks
of a given innovation.
Ultimately, however, it is not the technology alone that
will determine the potential benefits and risks of nan-
otechnology-based innovations. The applications, oper-
ating conditions and contexts in which they are used
are at least as important in this regard. The more the
effects of materials, processes and products are deter-
mined by the purpose and context in which they are
used, the greater the need to draw on additional design
principles relating specifically to those purposes and
contexts. The need for dialogue is thus likely to increase
rather than decrease.
38 Cf. Anastas, Paul T. (1994): Benign by Design Chemistry, ACS Symposium Series, Vol. 577
Figure 25: Nano cubes for hydrogen storage
51
Sustainable nanotechnologies – 13 design principles
Resource Efficiency Biomimeticsn Atomic efficiency and molecular n Use of local materials and energy sources
specificityn Self organisation as a manufacturing
n Energy efficiency across life cycle paradigm
-n Recyclability n Physiological manufacturing conditions
Energy and Environmental Minimum Risk Technologies Prevention/minimisation of:n Emissions reduction
n toxic substances and nanostructures or n Environmental monitoring morphologies which pose a risk to human
n Environmental remediation health or safety or to the environment
n Switch to renewable materials and n nanofunctionalities which pose a risk
energy sources to human health or safety or to the environment
n potential exposure
Figure 26: How the design principles are organised
2.5.3 Recommendations of the Working Groupon developing a shared paradigm for “Sus-tainable Nanotechnologies – Green Nano“
With many technological developments, the question of
what is scientifically and technically feasible and eco-
nomically desirable usually precedes any question of
potential risks or social acceptability. Approaches
involving technology development based on a shared
paradigm take a different path. Questions are first of all
asked regarding visions of the future that are supported
by society, and the technologies are then driven for-
ward in accordance with the desired goals of society.
Die Arbeitsgruppe empfiehlt:
Formulating a concept for further work on a
shared paradigm for “Sustainable Nanotechnolo-
gies – Green Nano” and coordinating this with the
responsible government bodies. When doing this,
consideration should be given to the Federal
Government’s High-Tech Strategy and Action Plan,
and to the coordinated research strategy of the
higher federal authorities. A review should be
carried out as to whether further research on the
paradigm and its design principles is needed.
Examining whether multi-stakeholder dialogue on
paradigms and principles could continue but with
a shifting of focus to specific sectors. Dialogue
events could help to focus attention specifically on
promoting innovation processes in accordance
with the “Green Nano” paradigm and provide a
forum for discussion on which innovations are
desirable and which are not, involving partici-
pants from manufacturers, user industries, small
and medium-sized enterprises, and representatives
of the scientific community, politics and public
administration, as well as NGOs.
52
Figure 27: Labelled 6 nm DNA strands on a silanised SiO2 surface
3 FINAL RECOMMENDATIONS OF THE NANOKOMMISSION
In the opinion of the NanoKommission, we must work
towards a culture of innovation in which investigation
and assessment of potential risks, responsible and safe
manufacture and use of nanomaterials and regulation
based on the principles of precaution and sustainability
are integrated into the innovation process at an early
stage. An innovation culture of this sort encompasses
several areas of activity:
Harnessing the innovative potential of nanotech-
nologies specifically to resolve important prob-
lems and tackle future challenges, especially those
relating to reducing pressure on the environment
and fostering advances in medicine and sustain-
able use of our limited natural resources.
Speeding up efforts to close current gaps in knowl-
edge regarding the potential impacts on human
53
health and on the environment of nanomaterials
and products manufactured using nanomaterials.
Exploring new methods of risk prevention by
agreeing on assessment procedures to enable
prompt preliminary assessment of nanomaterials
according to their potential risks and benefits,
prior to or complementing statutory regulation.
Responsible practice on the part of industry and
society regarding the development and placing on
the market of nanomaterials and nanoproducts.
Improving market transparency for consumers
regarding nanoproducts.
Early integration of sustainability objectives into
public research promotion and funding priorities
and corporate product development strategies.
The deliberations of the various NanoKommission
Issue/Working Groups revealed that while there was
certainly agreement on a range of general fundamental
issues, opinions differed widely on the need for socie-
tal/political activities, especially concerning issues
relating to regulation. This is also reflected in the final
recommendations of the NanoKommission.
3.1 NanoKommission recommendations onaccompanying social and risk-relatedresearch
The NanoKommission reiterates its recommendation
to the Federal Government from its first dialogue phase,
namely to develop a cross-departmental strategy for
research relating to safety and risk issues and to
increase funding significantly for research in these
areas. Efforts should focus on
closing the research gaps relating to risks in the
field of life-cycle management and prioritising
research on risks relating to consumer applica-
tions and environmental impacts of nanomateri-
als. Development of a cross-departmental strategy
for research should build on an evaluation of
previous research funding and set priorities in line
with activities in the international context, includ-
ing the 8th Framework Programme for Research
of the EU.
Research strategy development should be open to sug-
gestions from stakeholders in society. The NanoKommis-
sion agrees that responsibility in this regard should be
shared between ministries, their executive authorities
and industry. The NanoKommission advocates making a
list of current and completed research projects available
to the public on the internet and keeping it regularly
updated. At the time of writing, DECHEMA and VCI are
in also in the process of preparing a publication on
safety research in the chemical industry.
The NanoKommission recommends setting up a
central website under the auspices of a federal
authority to gather together the datasets from
risk-related and accompanying social research
conducted in Germany. This would allow SMEs in
particular to obtain a rapid overview of safety
research already undertaken. From an internation-
al perspective it would also be important to make
the publications available in English, and to inte-
grate the content into the OECD database.39
3.2 NanoKommission recommendations on the regulation of nanomaterialsand nanoproducts
In general, the NanoKommission acknowledges and
agrees with the findings of the Issue Group on regula-
tion of nanomaterials. Many of the considerations
addressed by the Group are likely to be taken up again
in the near future in the context of the revision of
European regulations, and indeed in some cases this
has already happened.
The NanoKommission believes that efforts currently
under way and actively supported by Germany to adopt
a uniform, standard definition of nanomaterials are
particularly important for progress in the debate on
regulation.
39 Cf. OECD Database, available at: http://webnet.oecd.org/NanoMaterials/Pagelet/Front/Default.aspx?
54
3.2.1 EU Regulations and Directives
The members of the NanoKommission consider the
REACH Regulation basically adequate for the purpose of
regulating substances at the nanoscale. When REACH
comes up for revision in 2012, however, some of its pro-
visions should be amended to include the specific
requirements of nanomaterials. In addition, the REACH
Annexes and the ECHA Guidance documents also need
to be brought up to date and amended in a timely man-
ner in the light of new research findings concerning
nanomaterials.
Priorities in this regard are:
Introduction of a definition of nanomaterials
Adjustment of requirements for provision of
information on nanoscale substances
Further review and, where appropriate, adjust-
ment of OECD testing methods and strategies
Provisions to incorporate nano-specific informa-
tion into Safety Data Sheets
Adjustment of transitional deadlines for the
registration of nanoscale substances
Reviewing the tonnage thresholds for a nano-spe-
cific assessment programme and chemical safety
reports based on it.
Some members of the NanoKommission and its Issue
Group felt there was a need to amend the provisions of
REACH in other respects too (see Section on this group).
The NanoKommission agrees that the EU Regulations
and Directives currently in force or in development in
the regulatory areas of “novel foods”, “food additives”
and “food contact materials” provide an adequate basis
for regulation of nanomaterials . Within the NanoKom-
mission, however, there are considerable differences of
opinion concerning the definition of nanomaterials,
labelling and laying down nano-specific testing proce-
dures as a prerequisite for registration, notification as
well as on authorisation of substances and products.
The NanoKommission basically considers the EU Regula-
tion on cosmetic products as a sound basis for the
regulation of nanoproducts. Some members, however,
are critical of
the relatively narrow definition of nanomaterials
in the Regulation
the fact that nanomaterials are not subject to an
authorisation requirement unless they are intend-
ed for use in products for which a positive list of
permitted substances exists (UV-filters, colourants
and preservatives)
the fact that the Regulation does not come into
effect until 2013.
The NanoKommission members recommend reviewing
current European legislation on biocidal products and
plant protection products to establish whether current
guidelines on testing adequately take into account the
specific properties of nanomaterials, or whether they
need to be amended. In doing so due attention should
be paid to the specific uses of plant protection products
and biocidal products.
Figure 28: Setting up laboratory experiment to test leaching in soil(in accordance with OECD Guideline 312)
55
3.2.2 Occupational health and safety
The NanoKommission underscores the recommenda-
tions for further work to establish general limits for
occupational health and safety and welcomes the pro-
posed cooperation between the Federal Institute for
Occupational Safety and Health (BAuA) and the German
Government’s Committee on Hazardous Substances
(AGS). It also suggests that this work be presented
rapidly in the international arena.
3.2.3 Product register
It was not possible to reach a common position on a
conception for a legally binding product register, its
function or its potential purpose. Industry representa-
tives consider the existing product lists and registers
based on REACH and EU legislation relating to cosmet-
ics, the food sector and plant protection products to be
sufficient. They expressed concerns that an additional
product register could potentially result in duplication
of current requirements regarding provision of informa-
tion. If introduced at all, a product register should only
include products with hazardous properties – and
nanoproducts and nanomaterials do not in themselves
possess hazardous properties. Other NanoKommission
members, meanwhile, stated a need for a legally bind-
ing nanoproduct register to create transparency for all
market participants (downstream users, distributors and
consumers) as well as for the public administration and
the legislator. Consumers should be able to choose for
themselves whether to buy particular products with
particular ingredients. A product register could also
assist authorities to take appropriate risk management
measures (e.g. product recall) by ensuring traceability of
nanomaterials.
3.2.4 Labelling
There are distinct differences of opinion within the
NanoKommission on the issue of voluntary or mandato-
ry labelling, and on the potential scope of labelling
schemes. Some NanoKommission members, especially
representatives of consumer and environmental protec-
tion organisations, favour compulsory labelling of all
nanomaterials intended for consumer use and applica-
tions that are open to the environment. Others, notably
industry representatives, hold the view that labelling
should only be required in certain cases.
3.3 NanoKommission recommendations onimplementation of the Principles forresponsible use of nanomaterials
During the past two years, the recommendations of
the previous NanoKommission for implementing the
principles it developed on responsible use of nanoma-
terials have not yet been acted upon. One reason for
this is undoubtedly lack of awareness of the principles.
Some companies have begun to apply the basic ideas
implicitly, but without making specific reference to
the NanoKommission’s Principles Paper. This, however,
makes it difficult to achieve the common goal of trans-
parent implementation of the Principles Paper
throughout the industry. With the exception of the
German paint and printing ink industry association,
which has produced corresponding guidelines, there
has scarcely been any success in communicating the
basic objectives of the Principles Paper to user indus-
tries at large.
The NanoKommission is aware that issues relating to
regulation are likely to take priority over ideas based on
voluntary measures within industry. Given that consen-
sus still prevails regarding the principles, however, the
NanoKommission expects much clearer steps to be tak-
en to implement the principles in a transparent man-
ner within industry. Civil society representatives in par-
ticular in the NanoKommission consider this to be vital
in terms of public confidence in the responsible devel-
opment of nanotechnologies. Success in this regard will
require better information on the Principles Paper
being made available by the sectoral bodies involved in
the NanoDialogue, and active support for the process
on the part of the Federal Government.
The NanoKommission recommends:
That action should be taken by both public admin-
istration and industry to improve dissemination of
the principles in line with the proposals of the
Issue Group (see Section 2.2).
56
The NanoKommission reaffirms its recommenda-
tion from 2008 that the guidelines should be
expanded to include environmental and con-
sumer protection, as the first phase of the NanoDi-
alogue only addressed occupational health and
safety.
Developing a plan for monitoring implementa-
tion: in future prompt and continuous monitoring
should be carried out to ascertain whether meas-
ures put in place to promote dissemination and
awareness of the principles actually improve
implementation.
The NanoKommission would like to draw attention par-
ticularly to the German Statutory Accident Insurance
(DGUV), BASF SE, the German paint and printing ink
industry association and the Federal Institute for Occu-
pational Safety and Health (BAuA), all of which have
now expressed their explicit commitment to the
NanoKommission Principles. These pioneering activities
are seen as the first signs of success from the dialogue
process despite the fact that the overall findings of the
Issue Group were rather negative.
Another success of the dialogue process in the eyes of
the NanoKommission is the VCI’s initiative to raise
awareness of the principles by conducting a survey and
promote monitoring of their implementation jointly
with the stakeholders.
3.4 Recommendations for further work oncriteria for preliminary benefit-riskassessment
Given the complexity of the issues relating to nanoma-
terials and nanoproducts, only initial steps have been
taken towards developing practicable criteria for pre-
liminary benefit-risk assessment. Work on developing a
comprehensive matrix integrating benefit and risk
aspects has not yet been completed. Both of the Issue
Groups produced valuable contributions, notably
regarding continuous sustainability assessment of
nanoproducts throughout the product life cycle includ-
ing consideration of social aspects. Criteria for prelimi-
nary risk assessment of nanomaterials were also formu-
lated. The guidelines and list of criteria will help com-
panies to identify potential risks associated with particu-
lar development trajectories early on and steer develop-
ment towards safer alternatives. The work of the Groups
in this area should be continued in an appropriate
form. This requires further in-depth scientific study of
both benefit and risk criteria for which potential meas-
uring procedures need to be applied, and proposals
regarding appropriate interpretation of the results. The
purpose of this should be to establish how to evaluate
benefit and risk factors at an early stage, what key infor-
mation is already available or needs to be generated,
and where necessary what measures to take as a conse-
quence.
The NanoKommission recommends to the Federal
Government that the valuable work begun by the
two Issue Groups should be pursued, combining it
in a research and consultancy project. Where
appropriate, the advances in knowledge resulting
from the NanoDialogue should be consolidated
with a broad group of stakeholders.
The NanoKommission recommends carrying out
more practical testing in this area involving future
users in industry, including SMEs.
In this context it would be expedient to enhance
cooperation with the developers of the Swiss Pre-
cautionary Matrix, as they have already gained
experience of using preliminary risk assessment
tools and, where applicable, measures that need
to be taken as a result. The aim of this could ulti-
mately be to coordinate efforts and present them
jointly in the international arena.
3.5 Recommendations for developing andapplying a shared paradigm (Leitbild)for “Sustainable Nanotechnologies –Green Nano”
In the effort to foster a new culture of innovation in
Germany based on commitment to the principle of sus-
tainability and the precautionary principle, the search
for a socially acceptable, shared paradigm can provide
valuable support. The Working Group on “Sustainable
Nanotechnologies – Green Nano” came into being as a
result of additional interest in this area on the part of
57
NanoKommission members from the scientific commu-
nity, environmental organisations, industry and the
public administration. The resulting design principles
are seen as a useful basis, and it would be desirable to
develop them further. They could help to consider
societal concerns and needs early on in the process of
product development, and embed innovation strategies
in the social context. Innovations that are guided by
shared paradigms win society’s trust, without which
success in the market is not possible. If these paradigms
and their design principles are developed in an open
manner involving a variety of stakeholders, public
confidence in the players will probably increase.
The NanoKommission therefore recommends to the FederalGovernment:
To promote research and development into a
shared paradigm (Leitbild) for sustainable develop-
ment of nanotechnologies and nanotechnology
design principles and to disseminate these to a
broad range of players in basic research, acade-
mies, scientific organisations and trade associa-
tions, in research promotion and funding bodies,
in corporate research and development and
corporate strategic development. This process
should also be opened up into a multi-stakeholder
process.
3.6 Outlook for the German NanoDialogue
The members of the NanoKommission assume that
debate in German society concerning the potential ben-
efits and risks of nanotechnologies will continue. The
number of nanoproducts on the market or soon to be
placed on the market will continue to rise. Over the
next two years, key issues concerning regulation will be
addressed and decided, especially at EU level, but also
in Germany.
The NanoKommission therefore recommends to the FederalGovernment:
To continue the dialogue on nanotechnology in
an appropriate manner, ensuring continued
involvement of the current NanoDialogue
partners. Topics that should be covered in
dialogue events include:
The state of regulatory processes relating to
nanotechnology in the EU
Current activities in the OECD on the issue of
nanotechnology
Current national activities on nanotechnologies
such as regulatory processes, implementation of
the Federal Government’s Action Plan, cross-
departmental strategy on research, particularly
research on safety and risk issues concerning nan-
otechnologies, and on issues concerning informa-
tion for consumers and consumer protection.
In addition, the NanoKommission recommends:
Holding an annual central dialogue event to foster
cooperation among stakeholders, to facilitate
exchange and expansion of knowledge by means
of face-to-face encounter, and to debate the use of
nanotechnologies in different sectors.
The NanoKommission reiterates its suggestion that
the Federal Government should establish a nation-
al, cross-departmental internet platform providing
information on developments and activities in the
field of nanotechnologies.
58
4 ANNEX
List of abbreviationsA: Arbeitnehmer/Arbeiter (employees)
AGS: Ausschuss für Gefahrstoffe bei der Bundesanstalt für Arbeitsschutz und Arbeitsmedizin (BauA – http://www.baua.de/prax/ags) – BAuA Committee on Hazardous Substances
BAM: Bundesanstalt für Materialforschung und -prüfung – Federal Institute for Materials Research and Testing
BAuA: Bundesanstalt für Arbeitsschutz und Arbeitsmedizin (www.baua.de) – German Federal Institute for Occupational Safety and Health
BfR: Bundesinstitut für Risikobewertung – Federal Institute for Risk Assessment
BGBl: Bundesgesetzblatt – Federal Law Gazette
BIAC: Business and Industry Advisory Committee
BLAC: Bund/Länderausschuss für Chemikaliensicherheit (www.blac.de) – Federal/Länder Working Committeeon Chemical Safety
BLL: Bund für Lebensmittelrecht und Lebensmittelkunde e.V. (www.bll.de) – German Federation for Food Law and Food Science
BMAS: Bundesministerium für Arbeit und Soziales – Federal Ministry of Labour and Social Affairs
BMBF: Bundesministerium für Bildung und Forschung – Federal Ministry of Education and Research
BMELV: Bundesministerium für Ernährung, Landwirtschaft und Verbraucherschutz – Federal Ministry of Food,Agriculture and Consumer Protection
BMG: Bundesministerium für Gesundheit (www.bmg.bund.de) – Federal Ministry of Health
BMU: Bundesministerium für Umwelt, Naturschutz und Reaktorsicherheit – Federal Ministry for the Environment, Nature Conservation and Nuclear Safety
BMVg: Bundesministerium für Verteidigung – Federal Ministry of Defence
BMVBS: Bundesministerium für Verkehr, Bau und Stadtentwicklung – Federal Ministry of Transport, Building and Urban Development
BMWi: Bundesministerium für Wirtschaft und Technologie – Federal Ministry of Economics and Technology
BSU: Behörde für Stadtentwicklung und Umwelt, Hamburg (www.hamburg.de/bsu/) – Office for urban development and environment, Hamburg
BUND: Bund für Umwelt und Naturschutz Deutschland (www.bund.net) – Friends of the Earth Germany
BVL: Bundesamt für Verbraucherschutz und Lebensmittelsicherheit (http://www.bvl.bund.de) – Federal Office of Consumer Protection and Food Safety
BW: Baden-Württemberg
CLP: Classification, Labelling and Packaging – Regulation (EC) No 1272/2008 on classification, labelling andpackaging of substances and mixtures
CNT: carbon nanotube
COM: Communication from the European Commission to the European Parliament and the Council
DaNa: BMBF research project: DaNa - acquisition, evaluation and public-oriented presentation of society-relevant data and findings relating to nanomaterials (www.nanopartikel.info/cms)
59
DECHEMA: Gesellschaft für Chemische Technik und Biotechnologie e.V. – Society for Chemical Engineering andBiotechnology
DFG: Deutsche Forschungsgemeinschaft (www.dfg.de) – German Research Foundation
DGB: Deutscher Gewerkschaftsbund (www.dgb.de) – Confederation of German Trade Unions
DGUV: Deutsche Gesetzliche Unfallversicherung (www.dguv.de) – German Statutory Accident Insurance
DHMD: Deutsches Hygiene-Museum Dresden (www.dhmd.de) – German foundation and museum of health education and health care, Dresden
DIN: Deutsches Institut für Normung (www.din.de) – German Institute for Standardisation
DMM: Deutsches Museum München – German Museum Munich
DNA: Deoxyribonucleid acid
DNEL: Derived no-effect level
EC: European Community
ECHA: European Chemicals Agency (http://echa.europa.eu)
EFSA: European Food Safety Authority
EN: European Standard
EU: European Union
FhG: Fraunhofer-Gesellschaft (www.fraunhofer.de) – a German applied research organisation
FTIR: Fourier transform infrared spectroscopy. Spectroscopic method permitting qualitative and quantitative determination of diverse components even when detection limits are low and measurement ranges wide.
GdCH: Gesellschaft Deutscher Chemiker – German Chemical Society
HGF: Helmholtz-Gemeinschaft Deutscher Forschungszentren (www.helmholtz.de) – Helmholtz Association ofGerman Research Centres
HLPUG: Hessisches Landesprüfungs- und Untersuchungsamt im Gesundheitswesen – Land of Hesse bureau fortesting and research in public health care
IFA: Institut für Arbeitsschutz der DGUV – Institute for Occupational Safety and Health of the DGUV
IG BCE: Industriegewerkschaft Bergbau – Chemie – Energie – German Union of mining, chemical and energyindustry workers
IME: Fraunhofer-Institut für Molekularbiologie und Angewandte Ökologie (www.ime.fraunhofer.de) – Fraunhofer Institute for Molecular Biology and Applied Ecology
InnoZent OWL: InnovationsZentrum für Internettechnologie und Multimediakompetenz der Region Ostwestfalen-Lippe – Innovation Centre for Internet Technology and Multimedia Competence in the Ostwestfalen-Lippe Region
INOS: Forschungsprojekt des BMBF: Identifizierung und Bewertung von Gesundheits- und Umweltauswirkun-gen von technischen nanoskaligen Partikeln – Research project of the Federal Ministry of Education and Research on identification and assessment of the impacts on health and on the environment ofengineered nanoscale particles
IKW: Industrieverband Körperpflege und Waschmittel – German Cosmetic, Toiletry, Perfumery and Detergent Industry Association
ISO: International Organization for Standardization (www.iso.org)
IUCLID: International Uniform Chemical Information Database
IUPAC: International Union of Pure and Applied Chemistry
60
IUTA: Institut für Energie- und Umwelttechnik e.V. (www.iuta.de) – Institute of Energy and Environmental Technology
JRC: Joint Research Centre
LAUG: Länderarbeitsgruppe Umweltbezogener Gesundheitsschutz – Working Group of the German Länder on environmental health
LFGB: Lebensmittel- und Futtermittelgesetzbuch – German Food and Feed Code
LUBW: Landesanstalt für Umwelt, Messungen und Naturschutz Baden-Württemberg – Institute for the Environment, Measurements and Nature Conservation of the Land of Baden-Württemberg
MAK-Kommission: Senatskommission zur Prüfung gesundheitsschädlicher Arbeitsstoffe(http://www.dfg.de/dfg_profil/gremien/senat/gesundheitsschaedliche_arbeitsstoffe/index.html) – German Research Foundation’s Senate Commission for the Investigation of Health Hazards of ChemicalCompounds in the Work Area
MPG: Max-Planck-Gesellschaft (www.mpg.de) – Max Planck Society
NGO: Non-governmental organisation
NM: Nanomaterial
nm: Nanometre
NP: Nanoparticle
OECD: Organisation for Economic Cooperation and Development (www.oecd.org)
OLED: Organic light-emitting diode
PBT: Persistent, bioaccumulative and toxic
PET: Polyethylene terephthlatate
PNEC: Predicted no effect concentration
PPP: Plant protection product
REACH: Regulation (EC) No 1907/2006 concerning the registration, evaluation, authorisation and restriction of chemicals
RoHS: Restriction of Hazardous Substances
SCCP: Scientific Committee on Consumer Products
SCENHIR: Scientific Committee on Emerging and Newly Identified Health Risks
SE: Societas Europaea – European Company (public company under European law)
SiO2: Silicon dioxide
SME: small and medium-sized enterprises
SRU: Sachverständigenrat für Umweltfragen – German Advisory Council on the Environment
StMUGV: Land Ministry for the Environment, Health and Consumer Protection, Bavaria
TEGEWA: Verband der Textilhilfsmittel-, Lederhilfsmittel-, Gerbstoff- und Waschrohstoff-Industrie e.V., Frankfurt(www.tegewa.de) – Frankfurt-based trade association of the German chemical industry serving manufacturers of processing aids for the textile, leather and tanning industries and of detergent bases
TFEU: Treaty on the Functioning of the European Union
TÜV: Technischer Überwachungs-Verein – German Technical Inspection Association
TUHH: Technische Universität Hamburg-Harburg – Hamburg University of Technology
TRGS: Technische Regeln für Gefahrstoffe – German technical regulations on hazardous substances
61
TWG: Technical working group
U: Umwelt – Environment
UBA: Umweltbundesamt (www.umweltbundesamt.de) – German Federal Environment Agency
UFT: (Zentrum für) Umweltforschung und nachhaltige Technologien, Universität Bremen (www.uft.uni-bre-men.de) – (Centre for) Environmental Research and Sustainable Technology, University of Bremen
UfU: Unabhängiges Institut für Umweltfragen e.V. (www.ufu.de) – Independent Institute for Environmental Concerns
UMK: Umweltministerkonferenz (der deutschen Bundesländer) – Conference of Environment Ministers (of the German Länder)
UV: Ultraviolet
V: Verbraucher – consumers
VCI: Verband der chemischen Industrie e.V. (www.vci.de) – German Chemical Industry Association
VDI: Verein Deutscher Ingenieure e.V., Düsseldorf (www.vdi.de) – Association of German Engineers
VdL: Verband der Lack- und Druckfarbenindustrie – German paint and printing ink industry association
VSMK: Verbraucherschutzministerkonferenz (der Länder und des Bundes – www.verbraucherschutzministerkonferenz.de) – Conference of Consumer Protection Ministers (of the German Federal Republic and Länder)
VZBV: Verbraucherzentrale Bundesverband e.V. (www.vzbv.de) – Federation of German Consumer Organisations
WECE: Women in Electrical and Computer Engineering (www.wece.ece.ufl.edu/)
WG: Working group
WGL: Wissenschaftsgemeinschaft Gottfried Wilhelm Leibniz e.V., Bonn (www.leibniz-gemeinschaft.de) – Gottfried Wilhelm Leibniz Scientific Community, known as the Leibniz Association, Bonn
WoE: Weight of Evidence
WPMN: Working Party on Manufactured Nanomaterials
ZGV: Zentrum Gesellschaftliche Verantwortung der Evangelischen Kirche in Hessen und Nassau(www.zgv.info/) – Centre for Social Responsibility of the Protestant Church in Hesse and Nassau
Links for further informationLinks to guidelines addressed by the Issue Group on principles
Federal/Länder authorities
Bundesanstalt für Arbeitsschutz und Arbeitsmedizin (BAuA – Federal Institute for Occupational Safety and Health) / Verband der Chemischen Industrie e.V. (VCI – German Chemical Industry Association): Leitfaden für Tätigkeiten mit Nanomaterialien am Arbeitsplatz (Guidelines for activities involving nanomaterials in theworkplace) www.baua.de/de/Themen-von-A-Z/Gefahrstoffe/Nanotechnologie/pdf/Leitfaden-Nanomaterialien.pdf
DGUV: Positionspapier der Deutschen Gesetzlichen Unfallversicherung zum verantwortungsvollen Umgang mit Nanoma-terialien (German Statutory Accident Insurance position paper on the responsible use of nanomaterials)www.dguv.de/inhalt/praevention/themen_a_z/nano/index.jsp
Hessen-Nanotech: Informationsplattform Nano-Sicherheit (Information platform nano-safety)
www.nano-sicherheit.de
62
Hessen-Nanotech: Supplement "Innovationsfördernde Good-Practice-Ansätze zum verantwortlichen Umgang mit Nanoma-terialien" (Supplement on “Fostering innovation through good-practice approaches to responsible use of nanomaterials”)www.hessen-nanotech.de/mm/Suppl-NanoKomm_final_Web.pdf
Hessen-Nanotech: Sichere Verwendung von Nanomaterialien in der Lack- und Farbenbranche – Ein Betriebsleitfaden (Safe use of nanomaterials in the paint and printing ink industry – Company guidelines) www.hessen-nanotech.de/mm/Betriebsleitfaden_NanoFarbeLacke_Vorab.pdf
IFA – Institute for Occupational Safety and Health of the German Statutory Accident Insurance:Schutzmaßnahmen bei ultrafeinen Aerosolen und Nanopartikeln am Arbeitsplatz (Protective measures relating to ultra-fine aerosols and nanoparticles in the workplace) www.dguv.de/bgia/de/fac/nanopartikel/schutzmassnahmen/index.jsp
LUBW Landesanstalt für Umwelt, Messungen und Naturschutz Baden-Württemberg (Institute for the Environment, Measurements and Nature Conservation of the Land of Baden-Württemberg):Nanomaterialien – Arbeitsschutzaspekte (Nanomaterials – Occupational health and safety issues)www.lubw.baden-wuerttemberg.de/servlet/is/6644/?shop=true
Industry bodies
Verband der Chemischen Industrie e.V. (VCI – German Chemical Industry Association): Responsible Production and Use ofNanomaterials www.vci.de/default~cmd~shd~docnr~122306~lastDokNr~-1.htm
Industrieverband Körperpflege- und Waschmittel e.V. (IKW – German Cosmetic, Toiletry, Perfumery and Detergent Industry Association): Sicherheitsbeurteilung für Pflege- und Reinigungsmittel, die Nanomaterialien enthalten und/oderNanoschichten erzeugen (Safety assessment of body care and cleaning products which contain nanomaterials or formnano-layers) www.ikw.org/pdf/broschueren/Nano_d.pdf
Industrieverband Körperpflege- und Waschmittel e.V. (IKW – German Cosmetic, Toiletry, Perfumery and Detergent Industry Association): Nanopartikel in kosmetischen Mitteln (Nanoparticles in cosmetic products) www.ikw.org/pdf/broschueren/Nano_IKW231107.pdf
Verband der deutschen Lack- und Druckfarbenindustrie e.V.(VdL – German paint and printing ink industry association):Standpunkt zum Verantwortlichen Umgang mit Nanomaterialien in der Lackindustrie (Position on responsible use ofnanomaterials in the paint industry) www.lackindustrie.de/default2.asp?cmd=shd&docnr=125998&rub=651&tma=1&nd=
Verband der deutschen Lack- und Druckfarbenindustrie e.V. (VdL – German paint and printing ink industry association):VdL-Leitfaden für den Umgang mit Nanoobjekten am Arbeitsplatz (VdL guidelines for the use of nano-objects in the work-place) www.lackindustrie.de/default2.asp?rub=676&tma=728&cmd=shd&docnr=127627&nd=&ond=tv
Companies
BASF SE: Guide to safe manufacture and for activities involving nanoparticles at workplaces in BASF AGwww.basf.com/group/corporate/de/content/sustainability/dialogue/in-dialogue-with-politics/nanotechnology/employees
BASF AG: Code of Conduct Nanotechnologywww.basf.com/group/corporate/de/sustainability/dialogue/in-dialogue-with-politics/nanotechnology/code-of-conduct
Evonik Degussa GmbH: Nanotechnologie – Sichere Produktion (Nanotechnology – safe production)www.degussa-nano.com/nano/de/nachhaltigkeit/sicherheit/
Bayer MaterialScience: Nanomaterial Product Stewardship (registration required for access)http://baycareonline.com/nano_stewardship.asp
Bayer Code of Good Practice for safe handling of nanomaterials in production and on-site usehttp://baycareonline.com/nano_stewardship.asp
63
4.5 Lists of participants
NanoKommission of the German Federal Government
Name Institution
ChairmanSt a.D. Wolf-Michael Catenhusen
Chairman of the NanoKommission
Prof. Dr. Christian Calliess Freie Universität Berlin, School of Law
Patricia Cameron Friends of the Earth Germany – BUND
Dr. Rainer Jansen Federal Ministry of Education and Research – BMBF
Michael Jung Nanogate AG
Dr. Martin Kayser BASF AG
Dr. Holger Krawinkel Federation of German Consumer Organisations – vzbv
Dr. Peter Markus Evangelische Akademie Villigst (Protestant Academy, Villigst)
Dr. Thomas Müller-Kirschbaum Henkel AG & Co. KGaA
Dr. Hanns Pauli Confederation of German Trade Unions – DGB
Dr. Gerd Romanowski German Chemical Industry Association – VCI
Dr. Peter Rudolph (from 31.3.2010) Ministry for the Environment, Health and Consumer Protection of theLand of Brandenburg (MUGV)
MinDirig. Hubert SteinkemperFederal Ministry for the Environment, Nature Conservation and NuclearSafety – BMU
MinDirig. Dr. Walter Töpner Federal Ministry of Food, Agriculture and Consumer Protection -BMELV
Prof. Dr. Arnim von Gleich University of Bremen
Dr. Hans-Jürgen Wiegand EVONIK Degussa GmbH
Dr. Peter Wolfgardt (until 3.3.2010)Bavarian Land Ministry of Labour and Social Order, Family and Women– StMAS
Expert support – BMU
Dr. Anke JesseFederal Ministry for the Environment, Nature Conservation and NuclearSafety – BMU
Cornelia LeuschnerFederal Ministry for the Environment, Nature Conservation and NuclearSafety – BMU
Organisational support
Dirk Jepsen Ökopol GmbH
Antonia Reihlen Ökopol GmbH
Silke Detlefs Ökopol GmbH
Final report
St a.D. Wolf-Michael Catenhusen Chairman of the NanoKommission
Dr. Antje Grobe Stiftung Risiko-Dialog (Risk Dialogue Foundation)
64
Issue Group on implementation of the Five Principles
Name Institution
Spokesperson of the Issue Group:
Dr. Torsten Wolf* Federal Institute for Occupational Safety and Health – BAuA
Dr. Heidi Becker* Federal Environment Agency – UBA
Dr. Markus Berges IFA – Institute for Occupational Safety and Health, DGUV
PD Dr. Gaby-Fleur Böl / Dr. Astrid Epp* Federal Institute for Risk Assessment – BfR
Dr. Dietmar Eichstädt German paint and printing ink industry association – VdL
Dr. Gabriela Fleischer Consumer Council, German Institute for Standardisation – DIN
Cornelia Leuschner* Federal Environment Ministry (BMU), Division IG II 6
Dr. Carolin Kranz BASF SE
Prof. Dr.-Ing. Wilfried Kühling Friends of the Earth Germany – BUND
Dr. Jürgen Milde German Statutory Accident Insurance – DGUV
Dr. Ralf Nehring*LAUG, Ministry of the Environment, Forestry and Consumer Protection
Dr. Jacques Ragot Bayer Material Science AG
Dr. Martin Reuter German Chemical Industry Association – VCI
Dr. Sieglinde Stähle German Federation for Food Law and Food Science – BLL
Dr. Frank Vogelsang Rhineland Protestant Academy
Henning WriedtBeratungs- und Informationsstelle Arbeit & Gesundheit (Occupational Health Advice and Information Centre)
Silke Detlefs Ökopol GmbH
* As the Federal Government is the recipient of the NanoKommission’s recommendations, representatives of the various government bodies have adifferent role to that of the stakeholders in the Issue Group. Participants from the federal ministries and institutions within the ministries’ remitswere mandated to provide expertise and advice to support the work of the Issue Group. Expert input provided by these individuals does not neces-sarily represent the official position of the ministry concerned.
65
Issue Group on guidelines for collecting data and comparing benefit and risk aspects of nanoproducts
Name Institution
Spokesperson of the Issue Group:Michael Jung
Nanogate AG
Ralf Bosse Schmitz-Werke GmbH & Co. KG
Alexandra Caterbow / SonjaHaider / Doris Möller
Women in Europe for a Common Future – WECF
Dr. Sabine Dippner*Federal/Länder Working Committee on Chemical Safety / Office forurban development and environment, Hamburg – BLAC /BSU
Dr. Wolfgang Dubbert* Federal Environment Agency – UBA
Dr. Alex Föller TEGEWA
Dr. Roland Franz Fraunhofer Institute for Process Engineering and Packaging
Dr. Peter German Expert in environmental medicine
Dr. Ralf Greiner* Max Rubner Institute
Dr. Ilka Grötzinger* Federal Ministry of Health – BMG
Dr. Georg Hofmeister Hofgeismar Protestant Academy
Prof. Dr. Rüdiger Iden BASF SE
Dr. Anke Jesse*Federal Ministry for the Environment, Nature Conservation and Nuclear Safety – BMU
Andreas Keil InnoZent OWL
Dr. Peter Krüger Bayer MaterialScience AG
Cornelia Leuschner*Federal Ministry for the Environment, Nature Conservation and Nuclear Safety – BMU
Dr. Wolfgang Luther Association of German Engineers – VDI, Technologiezentrum GmbH
Christina Meßner Gesamtverband Textil und Mode – Textile and Fashion Confederation
Dr. Asmus Meyer-Plath* Federal Institute for Materials Research and Testing – BAM
Dr. Karin Michel Henkel AG & Co. KG aA
Martin Möller Öko-Institut e.V. (Institute of Applied Ecology)
Isabelle MühleisenFederation of German Consumer Organisations, North-Rhine Westphalia
Stefan Ruholl Schmitz – Werke GmbH & Co. KG
Rüdiger Stegemann Friends of the Earth Germany – BUND
Elke Walz* Max Rubner Institute
Dr. Heinz Zeininger Siemens AG
Silke Detlefs Ökopol GmbH
Antonia Reihlen Ökopol GmbH, Moderator
66
Issue Group on criteria for preliminary assessment of nanomaterials with regard to their impacton human health and the environment
Name Institution
Spokesperson of the Issue Group: Dr. Kerstin Hund-Rinke
Fraunhofer Institute for Molecular Biology and Applied Ecology
Dr. Rolf BuschmannFederation of German Consumer Organisations, North-Rhine Westphalia
Prof. Dr. Thomas Gebel* Federal Institute for Occupational Safety and Health – BAuA
Dr. Mario Götz* Federal Institute for Risk Assessment – BfR
Stefan Grötschel* Federal Institute for Occupational Safety and Health – BAuA
Stephan HackmannCentre for Environmental Research and Sustainable Technology(UFT), University of Bremen, (Confederation of German TradeUnions – DGB)
Dr. Anke Jesse*Federal Ministry for the Environment, Nature Conservation andNuclear Safety – BMU
Oliver Kalusch BBU (Federal Association of Environmental Action Groups)
Dr. Harry Keidel*Ministry of the Environment, Forestry and Consumer Protection,Rhineland-Palatinate
Dr. Nils Krüger Evonik Degussa GmbH
Dr. Thomas Kuhlbusch Institute of Energy and Environmental Technology – IUTA
Cornelia Leuschner*Federal Ministry for the Environment, Nature Conservation andNuclear Safety – BMU
Dr. Hubert MeisingerProtestant Church of Hesse and Nassau / Centre for Social Responsibility – ZGV
Dr. Karin Michel Henkel & Co. KGaA
Prof. Dr. Hartwig Muhle Friends of the Earth Germany – BUND
Dr. Barbara-Christine Richter Bayer Material Science AG
Jan Henrik Schlattjan* Land of Hesse Bureau for testing and research in the public health sector – HLPUG
Katja Stephan Forschungszentrum Jülich GmbH
Dr. Doris Völker* Federal Environment Agency – UBA
Dr. Karin Wiench BASF SE
Dr. Petra Wolff* Federal Ministry of Education and Research – BMBF
Dr. Sibylle Zielke*LAUG, Ministry of Social Affairs, Women, Family and Health, Lower Saxony
Silke Detlefs Ökopol GmbH
Antonia Reihlen Ökopol GmbH, Moderator
67
Issue Group on reviewing regulation of nanomaterials and nanoproducts
Name Institution
Spokesperson of the Issue Group:Prof. Dr. Christian Calliess
Freie Universität Berlin, School of Law
Katharina Adler** Federal Ministry of Food, Agriculture and Consumer Protection – BMELV**
Inga Beer* Federal Environment Agency – UBA
Elmar Böhlen* Federal Institute for Occupational Safety and Health – BAuA
Monika Büning Federation of German Consumer Organisations – vzbv
Dagmar Friese* Federal Ministry of Health – BMG
Prof. Dr. Martin Führ Darmstadt University of Applied Sciences
Dr. Ilka Grötzinger* Federal Ministry of Health – BMG
Andreas Hermann Öko-Institut e.V. (Institute of Applied Ecology)
Dr. Rolf Hertel* Federal Institute for Risk Assessment – BfR
Liane Horst* Federal Ministry of Education and Research – BMBF
Dr. Anke Jesse*Federal Ministry for the Environment, Nature Conservation and NuclearSafety – BMU
Dr. Helmut Klein* Federal Ministry of Labour and Social Affairs – BMAS
Dr. Hans-Jürgen Klockner German Chemical Industry Association – VCI
Dr. Nils Krüger Evonik Degussa GmbH
Martina Kohlhuber*LAUG, Bavarian Land Office for Health and Food Safety – EnvironmentalHealth
Dr. Dietmar Kopp* Federal Ministry of Economics and Technology – BMWi
Cornelia Leuschner*Federal Ministry for the Environment, Nature Conservation and NuclearSafety – BMU
Dr. Hanns Pauli Confederation of German Trade Unions – DGB
Walther Quasigroch** Federal Ministry of Food, Agriculture and Consumer Protection – BMELV**
Dr. Marcus Schaper Loccum Protestant Academy
Dr. Jutta Schaub* Federal Ministry of Food, Agriculture and Consumer Protection – BMELV
Prof. Dr. Arno Scherzberg University of Erfurt
Dr. Frauke Schröder* Federal Institute for Occupational Safety and Health – BAuA
Dr. Agnes Schulte* Federal Institute for Risk Assessment – BfR
Dr. Sieglinde Stähle German Federation for Food Law and Food Science – BLL
Jurek Vengels Friends of the Earth Germany – BUND
Dr. Heiner Wahl* Federal Ministry of Labour and Social Affairs – BMAS
Dr. rer. nat. Rudolf Weinand Evonik Degussa GmbH
Dr. Karin Wiench BASF SE
Silke Detlefs Ökopol GmbH
Antonia Reihlen Ökopol GmbH, Moderator
** Ms Adler and Mr Quasigroch provided support in written form but did not attend the Issue Group sessions
68
Working Group on developing a shared paradigm for “Sustainable Nanotechnologies – Green Nano”
Name Institution
Spokesperson of the Working Group:Prof. Dr. Arnim von Gleich
University of Bremen
Patricia Cameron Friends of the Earth Germany – BUND
St a.D. Wolf-Michael Catenhusen Chairman of the NanoKommission
Dr. Antje Grobe Stiftung Risiko-Dialog (Risk Dialogue Foundation)
Cornelia Leuschner* Federal Ministry for the Environment, Nature Conservationand Nuclear Safety – BMU
Dr. Gerd Romanowski German Chemical Industry Association – VCI
Dr. Klaus Günther Steinhäuser* Federal Environment Agency – UBA
Antonia Reihlen Ökopol GmbH, Moderator
69
List of Tables
Table 1: Matrix for evaluation of guidelines 29
Table 2: Comparison of potential benefit and risk aspects relating to nanoproducts 34
Table 3: Format of the list of criteria based on the example “Production volume” 37
List of Figures
Figure 1: Source: nano+art, Moellenbeck, S., 10 nm-tall bismuth stacks on silicon 8
Figure 2: Source: Schmitz-Werke: Folding arm awning with Swela Sunsilk Nano-Clean fabric 10
Figure 3: Source: Max Rubner Institute: Device for measuring particle size distribution 10
Figure 4: Source: BASF: Photovoltaic technology based on organic materials 11
Figure 5: Source: nano+art, Wittenburg, G.: Scanning electron microscopy image of a
coating material for implants (hydroxyapatite granule with stem cells) 13
Figure 6: Source: Sustech: Emulsion droplets 14
Figure 7: Source: Darmstadt Technical University, research programme on nanomaterials,
research group Prof. Jörg Schneider: Nanostructured titanium dioxide 15
Figure 8: Source: Max Rubner Institute: Scanning electron microscope as an imaging system 17
Figure 9: Source: BfR: Using fluorescence microscopy to analyse cells treated with nanoparticles 18
Figure 10: Source: BASF: X-Seed precast concrete components 21
Figure 11: Source: TUHH, Buschhorn, S.: Fracture surface of a nano-modified glass
fibre composite with CNT 24
Figure 12: Source: Evonik: Measuring nanoparticles with the aid of a scanning
mobility particle sizer (SMPS) 27
Figure 13: Source: BAuA: Using a shaker to test the release of nanomaterials under mechanical stress 28
Figure 14: Source: Schmitz-Werke: Folding arm awning with Swela Sunsilk Nano-Clean fabric 31
Figure 15: Source: Fraunhofer IST, Scanning electron microscope image of the surface of
a fabrictreated with a nano-based material 32
70
Figure 16: Source: BMELV: Testing for nanoclay migration from doped plastics 33
Figure 17: Source: TUHH, Buschhorn, S. Light microscopy examination of a fibre
composite component 39
Figure 18: Source: TUHH, Buschhorn, S.: Highly entangled aggregation of manufactured
carbon nanotubes 40
Figure 19: Source: BAuA: Carbon nanofibres – test samples under the scanning
electron microscope 41
Figure 20: Source: TUHH, Buschhorn, S.: Measuring out fine dusts and nanoparticles
in a glove box 43
Figure 21: Source: BAM: Plastic with nanoclay gas barrier 45
Figure 22: Source: BASF: OLEDS 48
Figure 23: Source: nano+art, Dick, S.: "Waterplay“, fibres made from cellulose acetate and
silicon dioxide, Philipps University Marburg, Department of Chemistry 48
Figure 24: Source: Degussa: Water drops on a lotus leaf 49
Figure 25: Source: BASF: Nano cubes for hydrogen storage 50
Figure 26: How the design principles are organised 51
Figure 27: nano+art, Abouzar, M.H.: Labelled 6 nm DNA strands on a silanised SiO2 surface 52
Figure 28: Source: IUTA: Setting up laboratory experiment to test leaching in soil
(in accordance with OECD Guideline 312) 54
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